Clinical Research Associate Jobs in Aurora, CO

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What will you be doing? Works on multiple trials within the Cross Therapeutic areas - Start up focus Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. Build strong relationships with site personnel to facilitate a smooth onboarding process. Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. Proactively identify and address any issues that may delay study initiation or affect trial deliverables. Maintain precise documentation to ensure readiness for inspections. Support sites during the activation phase until they achieve “Green Light” status for site opening. Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. Qualifications What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in the Denver area; near a major airport. Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Pay Range ($91,336.00 USD - $114,170.00USD) Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What will you be doing? * Works on multiple trials within the Cross Therapeutic areas - Start up focus * Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. * Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. * Build strong relationships with site personnel to facilitate a smooth onboarding process. * Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). * Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. * Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. * Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. * Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. * Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. * Proactively identify and address any issues that may delay study initiation or affect trial deliverables. * Maintain precise documentation to ensure readiness for inspections. * Support sites during the activation phase until they achieve "Green Light" status for site opening. * Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. * Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. Qualifications What do you need to have? * Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences * Must be located in the Denver area; near a major airport. * Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials * Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials * Knowledge of several therapeutic areas * Analytical/risk-based monitoring experience is an asset * Ability to actively drive patient recruitment strategies at assigned sites * Ability to partner closely with investigator and site staff to meet all of our study timelines * Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). * Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. * Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. * To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Pay Range ($91,336.00 USD - $114,170.00USD) Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. What ICON can offer you:Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within the Cross Therapeutic areas - Start up focus + Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. + Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. + Build strong relationships with site personnel to facilitate a smooth onboarding process. + Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). + Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. + Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. + Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. + Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. + Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. + Proactively identify and address any issues that may delay study initiation or affect trial deliverables. + Maintain precise documentation to ensure readiness for inspections. + Support sites during the activation phase until they achieve "Green Light" status for site opening. + Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. + Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. **What do you need to have?** + Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences + Must be located in the Denver area; near a major airport. + Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials + Knowledge of several therapeutic areas + Analytical/risk-based monitoring experience is an asset + Ability to actively drive patient recruitment strategies at assigned sites + Ability to partner closely with investigator and site staff to meet all of our study timelines + Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. + Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. _Pay Range ($_ _91,336.00_ _USD - $_ _114,170.00_ _USD)_ _Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level._ **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs + Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead + Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

University of Colorado Anschutz Medical Campus School of Medicine | Department of Psychiatry | Division of Addiction Science, Prevention and Treatment Job Title: Clinical Research Coordinator (Entry - Senior Level) #00831714 - Requisition: #36090 Job Summary: The Clinical Research Coordinator will be supporting several different research projects in the School of Medicine, Department of Psychiatry, Division of Addiction Science, Prevention and Treatment at the University of Colorado, Anschutz Medical Campus. This position will support research projects in the TrAIL (Translational Addiction Imaging Lab, (PI: Dr. Joseph Schacht). The primary focus of the TrAIL is developing pharmacological treatments for alcohol and substance use disorders. The successful applicant will have the opportunity to work on several NIH-funded projects, which involve the evaluation of novel medications to treat Alcohol Use Disorder and Cannabis Use Disorder and involve the use of genetic and neuroimaging measures and alcohol administration in the laboratory. This position is an ideal opportunity for a candidate pursuing a career or planning an advanced degree in medicine, public health, clinical psychology, neuroscience, biomedical research, or related fields in the future. Key Responsibilities: * Assist with the day-to-day operations of clinical trials. * Assist with recruitment and pre-screening of study participants. * Coordinate and run research visits including alcohol and cannabis self-administration and fMRI sessions. * Perform blood draws on research participants and process biological samples in the Department of Psychiatry Addiction Biology Lab. * Coordinate and run community research visits in a mobile pharmacology lab. * Perform data entry and quality assurance reviews on study databases. * Participate in weekly lab meetings with study PI, MD, and research team. Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit ******************* The Department of Psychiatry is one of the largest units in the UCD-SOM and is comprised of 5 Divisions. The CU Department of Psychiatry sets the standard for Education and Training of leaders in psychiatry and mental health care, conducts ground-breaking Research that aims to eradicate suffering due to psychiatric and substance use disorders, provides ready access to state of-the-art mental health preventions and interventions across the continuum of care, and collaborates with the community and other key stakeholders to promote well-being among all Coloradans. We accomplish this vision in a manner that respects, values and advocates for the dignity and worth of each individual and family. Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: * Medical: Multiple plan options * Dental: Multiple plan options * Additional Insurance: Disability, Life, Vision * Retirement 401(a) Plan: Employer contributes 10% of your gross pay * Paid Time Off: Accruals over the year * Vacation Days: 22/year (maximum accrual 352 hours) * Sick Days: 15/year (unlimited maximum accrual) * Holiday Days: 10/year * Tuition Benefit: Employees have access to this benefit on all CU campuses * ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Equal Employment Opportunity Statement: The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply. Qualifications: Minimum Qualifications: Entry Level: * Bachelor's degree in any field. * A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Intermediate Level: * Bachelor's degree in any field. * A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. * One (1) year of clinical research or related experience. Senior Level: * Bachelor's degree in any field. * A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. * Two (2) years of clinical research or related experience. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications: * Bachelor's degree in science or health related field. * Three (3) years of clinical research or related experience. * Phlebotomy certification or equivalent or willing to obtain certification at our expense. * Experience or comfort with handling biohazardous materials such as human blood, urine, and saliva samples. * Experience with REDCap surveys and data entry. * Experience conducting human subjects research visits or eligibility screenings. * A master's degree or higher in a mental health field (i.e., clinical psychology, counseling, social work). * Experience administering structured clinical interviews to research participants. Conditions of Employment: * Ability to work evenings and weekends as scheduled. Knowledge, Skills, and Abilities: * Knowledge and understanding of federal regulations and Good Clinical Practice (GCP). * Ability to communicate effectively, both in writing and orally. * Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. * Outstanding customer service skills. * Knowledge of basic human anatomy, physiology medical terminology. * Ability to interpret and master complex research protocol information. * Strong organizational skills with the ability to multitask and meet deadlines. * Proficiency in Microsoft Office Suite. How to Apply: For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position. 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address. Questions should be directed to: Quinton Powell, *************************************** Screening of Applications Begins: Applications will be accepted until finalists are identified, but preference will be given to complete applications received by March 3rd, 2025. Those who do not apply by this date may or may not be considered. Anticipated Pay Range: The starting salary range (or hiring range) for this position has been established as: Entry Level: $48,446 - $61,623 Intermediate Level: $52,721 - $67,061 Senior Level: $56,995 - $72,498 The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: ***************************** ADA Statement: The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ********************************. Background Check Statement: The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. Vaccination Statement: CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . Purpose and Scope: A Clinical Site Monitor serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Clinical Site Monitor will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: + Site Selection + Pre-trial assessment + Site level Study Participant recruitment/retention plans + Site Activation/Initiation + On-site and remote monitoring + Overall site relationship management in collaboration with other sponsor roles that interact with the site + Close-out activities Essential Job Responsibilities: + Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. + Develops meaningful site relationships through consistent collaborative communication and engagement. + May participate in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. + Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. + Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. + Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. + Ensure ongoing adequacy of site (facilities, staff) for trial conduct. + Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA + Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. + Ensures site non-IMP study supplies are adequate for trial conduct. + Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. + Oversees the appropriate destruction of clinical supplies. + Ensures site staff complete data entry and resolve queries within expected timelines. + Ensures validity and completeness of data collected at trial sites. + Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. + Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. + Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. + Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. + Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. + Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. + Prepares trial sites for close out, conduct final close out visit. + Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. + May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. Quantitative Dimensions: May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines. Organizational Context: Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Qualifications: Required + BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience. + 5 years onsite monitoring experience. + A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience. + Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. + Strong critical thinking and problem-solving skills. + Strong IT skills in appropriate software and company systems. + Willingness to travel up to 40% with overnight stay away from home. + Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language. + Good written and oral communication. Preferred: + Experience working cross-functionally and in matrix teams + Experience in executing Lead CSM role + Experience mentoring more junior site monitors or site managers + Experience working in early development studies Salary Range $122,500K - $175K (NOTE: Final salary could be more or less, based on experience) Benefits: + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Early Development Clinical Operations Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

University of Colorado Anschutz Medical Campus School of Medicine | Department of Psychiatry | Division of Addiction Science, Prevention and Treatment Job Title\: Clinical Research Coordinator (Entry - Senior Level) Position\: #00831714 - Requisition\: #36090 Job Summary: The Clinical Research Coordinator will be supporting several different research projects in the School of Medicine, Department of Psychiatry, Division of Addiction Science, Prevention and Treatment at the University of Colorado, Anschutz Medical Campus. This position will support research projects in the TrAIL (Translational Addiction Imaging Lab, (PI\: Dr. Joseph Schacht). The primary focus of the TrAIL is developing pharmacological treatments for alcohol and substance use disorders. The successful applicant will have the opportunity to work on several NIH-funded projects, which involve the evaluation of novel medications to treat Alcohol Use Disorder and Cannabis Use Disorder and involve the use of genetic and neuroimaging measures and alcohol administration in the laboratory. This position is an ideal opportunity for a candidate pursuing a career or planning an advanced degree in medicine, public health, clinical psychology, neuroscience, biomedical research, or related fields in the future. Key Responsibilities: Assist with the day-to-day operations of clinical trials. Assist with recruitment and pre-screening of study participants. Coordinate and run research visits including alcohol and cannabis self-administration and fMRI sessions. Perform blood draws on research participants and process biological samples in the Department of Psychiatry Addiction Biology Lab. Coordinate and run community research visits in a mobile pharmacology lab. Perform data entry and quality assurance reviews on study databases. Participate in weekly lab meetings with study PI, MD, and research team. Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit ******************* The Department of Psychiatry is one of the largest units in the UCD-SOM and is comprised of 5 Divisions. The CU Department of Psychiatry sets the standard for Education and Training of leaders in psychiatry and mental health care, conducts ground-breaking Research that aims to eradicate suffering due to psychiatric and substance use disorders, provides ready access to state of-the-art mental health preventions and interventions across the continuum of care, and collaborates with the community and other key stakeholders to promote well-being among all Coloradans. We accomplish this vision in a manner that respects, values and advocates for the dignity and worth of each individual and family. Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: Medical\: Multiple plan options Dental\: Multiple plan options Additional Insurance\: Disability, Life, Vision Retirement 401(a) Plan\: Employer contributes 10% of your gross pay Paid Time Off\: Accruals over the year Vacation Days\: 22/year (maximum accrual 352 hours) Sick Days\: 15/year (unlimited maximum accrual) Holiday Days\: 10/year Tuition Benefit\: Employees have access to this benefit on all CU campuses ECO Pass\: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Equal Employment Opportunity Statement\: The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply. Qualifications: Minimum Qualifications: Entry Level: Bachelor's degree in any field. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Intermediate Level\: Bachelor's degree in any field. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. One (1) year of clinical research or related experience. Senior Level: Bachelor's degree in any field. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Two (2) years of clinical research or related experience. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications: Bachelor's degree in science or health related field. Three (3) years of clinical research or related experience. Phlebotomy certification or equivalent or willing to obtain certification at our expense. Experience or comfort with handling biohazardous materials such as human blood, urine, and saliva samples. Experience with REDCap surveys and data entry. Experience conducting human subjects research visits or eligibility screenings. A master's degree or higher in a mental health field (i.e., clinical psychology, counseling, social work). Experience administering structured clinical interviews to research participants. <

LEW I S & ASSOCIATES is a leader in providing Legal and Administrative staffing services. We are a sole source staffing firm giving you convenient ways of working with us. We make every effort to ensure the highest degree of professionalism and integrity in the staffing process. We understand the demanding role of recruiting to source the highest level of legal professionals while incorporating proven, innovative, and successful recruiting techniques. Job Description Our client is seeking a litigation associate with two to four years of experience to join the Trial Department in its Denver office. This associate will work in all phases of commercial litigation, with an emphasis on intellectual property litigation, from pleading through trial and appeal. This associate will have the opportunity to take depositions, appear in court, and work closely with partners. Strong academic performance, excellent writing skills, and two to four years of litigation experience are required. Specifically, we are seeking someone who has experience beyond document review and has handled significant parts of active cases. Admission to the Colorado bar is a plus. Additional Information Only candidates that meet the requirements will be contacted.

The Study Coordinator will report to the ADx Revenue Cycle Manager. The Study Coordinator will serve as a liaison for all study work for all phases of the study, from conception to initiation, to closure. Prepares new study documentation file organization, maintaining both paper and electronic files with good quality. Develops study milestone reports based on signed scope of work (SOW) and includes all timelines, tests, and internal deliverables. Provides milestones and progress against milestones. Works with Pre-Analytical (PA) to ensure ordering directions for studies are organized, thorough, and aligned with SOW, manifest information, data report expectations and samples received. Assists in ordering, labeling, and quality review of ordering process. Help to detect and investigate discrepancies between client shipping manifests, data build, DTA (if applicable) and Scope of Work (SOW) contract, as directed by manager. Provides visibility into result timelines and deliverables. Monitors and measures performance against timelines and communicates internally on track or off track performance. Coordinates with Account Management, manager and laboratory information system (LIS) team to ensure reports are proactively set up for data pulls. Coordinates with Lab Supervisor and Quality (if applicable) quality control review of data in data tables for clients. Responsible for updating study progress project management tools. Maintains a working knowledge of project management tools such as Smart Sheet (or other Project Management software), IST tool, study tracker, etc. Maintains an understanding of the routine workflow of the laboratory and maintains a working, technical knowledge of each test performed, and specific methodologies used by the laboratory. Other Duties Performs all other duties as assigned. Competencies Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health. Decision Quality: Solutions prove to be correct and accurate when judged over time, understands and makes decisions that benefit the laboratory and the individual. Drive for Results: Productivity is above expectations, balances achieving individual goals with providing value to laboratory, volunteers for additional projects and identifies new initiatives and fills in for staff absences, takes responsibility for accuracy and timeliness of work product. Informing & Communicating: Informs coworkers/leadership of when work product may be affected, Identifies key issues to pursue for maximum input rather than arguing every point, demonstrates ability to restate others' positions accurately-reflecting both facts and feelings, maintains long-term objectives while resolving short-term challenges. Managing Change: Balances competing demands of multiple projects by setting priorities, communicating change, and meeting deadlines, recovers quickly from setbacks and maintains focus under stress, can handle multiple changes in direction or assignments, consistently learns quickly when facing new problems, embraces change and unfamiliar tasks, consistently analyzes both success and failure to determine how to improve, maintains open mind and willingness to try new ideas or approaches, Analyzes both success and failure to determine how to improve, has a desire to learn. Professional Relationships: Coaches others to appreciate workforce diversity, seeks value in diversity and differences, encourages positive attitude in others. Problem Solving: Considers customer implications and perceptions when approaching problems to proposing solutions, reconciles inconsistent details within SOPs or processes, able to identify problem or key issue, able to rapidly perform complex analysis, accurately assess situations, probes all potential sources for answers, can see hidden problems. Looks beyond the obvious and doesn't stop at the first answer. Supervisory or Managerial Responsibility None Travel None Core Values Be available to work as scheduled and report to work on time. Be willing to accept supervision and work well with others. Be well groomed, appropriately for your role and wear ID Badge visibly. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually. Promotes a workplace culture based on mutual respect and merit, where all individuals are treated fairly and provided with equal opportunity to contribute to the mission and goals of the institution. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures. Wears appropriate PPE as outlined by the infection control policies and procedures. Demonstrates compliance with all state, federal and all other regulatory agency requirements. Minimum Qualifications Education: Bachelor's degree in business, science, or related degree required. Work Experience: A minimum of (2) two years of recent and related work experience required. Special Training, Certification or Licensure: None Salary Range: $25.04 - $33.11 Benefits At National Jewish Health, we recognize that our outstanding faculty and staff are the essence of our organization. For every aspect of health care, our employees are our greatest asset. With that in mind, we have designed a valuable, comprehensive benefits package to meet the needs of our employees and their families. Comprehensive Medical Coverage: Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans. Paid Time Off: Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations. Dental & Vision Plans: Coverage effective the first of the month after hire. Retirement Savings: 403(b) plan with employer contributions after two years. Wellness Incentives: Earn up to $200 annually for preventive health activities. Tuition Reimbursement: Up to $5,250 annually for full-time and part-time employees. Child Care Assistance: Childcare Flex Spending Account (FSA) with annual employer contribution. Loan Forgiveness: Public Service Loan Forgiveness (PSLF) eligible employer. Disability & Life Insurance: Employer-paid plans and optional buy-up choices. Voluntary Benefits: Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan Exclusive Discounts: Savings on local services, insurance, and RTD bus passes. Application Deadline: This position will be open for a minimum of three days and until a top applicant is identified.

div name="main"div class="cl HeadSecondary"h2Job Details/h2/divdiv aria-label="Job Details" class="row" name="local_row"div class="col-md-6 local-tax-col local-ee" id="job DetailsLeftColumn" name="local_left"div class="row form RowStandard" id="Job Location-row" div class="form Line"div aria-label="Job Location" name="Job Location"span aria-label="Job Location" class="" name="level"Lakewood Clinic - Lakewood, CO/span/div/div/divdiv class="row form RowStandard" id="Position Type-row" div class="form Line"div aria-label="Position Type" name="Position Type"span aria-label="Position Type" class="" name="level"Full Time/span/div/div/divdiv class="row form RowStandard" id="Education Level-row" div class="form Line"div aria-label="Education Level" name="Education Level"span aria-label="Education Level" class="" name="level"High School/span/div/div/div/divdiv class="col-md-6 local-tax-col local-client" name="local_right"div class="row form RowStandard" id="Salary Range-row" div class="form Line"div aria-label="Salary Range" name="Salary Range"span aria-label="Salary Range" class="" name="level"$26.00 - $31.00 Hourly/span/div/div/divdiv class="row form RowStandard" id="Job Category-row" div class="form Line"div aria-label="Job Category" name="Job Category"span aria-label="Job Category" class="" name="level"Research/span/div/div/div/div/divdiv class="cl HeadSecondary"h2Description/h2/divdiv aria-label="Description" class="row" name="description" style="word-wrap: break-word;"div class="row form RowStandard" id="job Desc-row" div class="form Line"span class="fb Text ignore-global-css" name="job Desc"p style="text-align:center;"/p p style="text-align:center;" /p p style="text-align:center;"span style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongemspan style="background-color:#ffffff;"span style="color:#000000;"Are you interested in making a difference in patient care? Learn about our unique culture of respect, growth, innovation, the best patient care, and how we give back to the community./span/span/em/strong/span/span/p p style="text-align:center;" /p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="background-color:#ffffff;"span style="color:#000000;"At strongem United Urology Group/em/strong, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care. /span/span/span/span/p p /p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="background-color:#ffffff;"span style="color:#000000;"We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff! /span/span/span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="background-color:#ffffff;"span style="color:#000000;"We deliver a cohesive approach to urologic care that provides patients access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies./span/span/span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="background-color:#ffffff;"span style="color:#000000;"We offer competitive salaries and a great work/life balance: emenjoy your weekends!/em/span/span/span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!/span/span/li /ul p /p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongemspan style="background-color:#ffffff;"span style="color:#000000;"United Urology Group /span/span/em/strongspan style="background-color:#ffffff;"span style="color:#000000;"is regarded as the leading urology network in the country. Our Urology Group Affiliates consist of Chesapeake Urology, Arizona Urology- Phoenix amp; Scottsdale, Arizona Urology - Tucson, Colorado Urology amp; Tennessee Urology./span/span/span/span/p p /p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strong Position Summary:/strong/span/span/p p /p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="color:#000000;"The strong Research Coordinator/strong will screen, enroll, and follow study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are in study. /span/span/span/p p /p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Primary Duties amp; Responsibilities:/span/strong/span/span/p p /p puspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Conducting Clinical Trials/span/strong/span/span/u/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="color:#000000;"Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Review the protocol and the informed consent form for accuracy and clarity./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP)./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Schedule site Sponsor visits in accordance with internal SOP./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory Specialist, when applicable./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Ensure maintenance and calibration of site study required equipment./span/span/span/li /ul puspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Enrollment of Study Subjects/span/strong/span/span/u/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="color:#000000;"Review the study design and inclusion/exclusion criteria with the PI/SI and, if needed, the Sponsor to ensure understanding. /span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Review, verify, and record/collect all relevant documentation in the subject's medical record needed to confirm study eligibility. /span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Review the protocol, informed consent form, and follow-up procedures with the potential study subjects./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Ensure the current approved informed consent is signed before subjects are screened and enrolled./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Inform and document notification of the subject's Primary Care Physician of trial participation if approved by the subject. /span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Perform delegated Protocol specific tasks as assigned by Principal Investigator. /span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Ensure that the randomization procedures are followed and documented per protocol guidelines./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Document protocol exemptions and deviations as appropriate. Ensure duplication of each for filing in the subject source and with the regulatory specialist. /span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOP. /span/span/span/li /ul puspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Follow-Up Procedures/span/strong/span/span/u/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="color:#000000;"Schedule subjects for follow-up visits, collect subjects' responses to therapy, and interview subjects for adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during the subject visit for any notable medical/medication changes from the last research visit. /span/span/span/li lispan style="color:#000000;font-family:Calibri, sans-serif;"span style="font-size:11pt;"Review laboratory data and communicate abnormal values to the PI/SI /spanspan style="font-size:14.6667px;"and/spanspan style="font-size:11pt;" as needed, primary care provider or specialist if additional medical attention is needed./span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Assess and document subject compliance and accountability with Investigational Product (IP). Document re-education when appropriate. /span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Communicate with research staff to ensure timely and accurate study drug distribution when applicable./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Record all Adverse Events outlined in protocol and review them with the PI/SI./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject's primary care physician or specialist./span/span/span/li /ul pustrongspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="color:#000000;"Administrative/Clerical/span/span/span/strong/u/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"span style="color:#000000;"Reporting all Deviations/Adverse/SAE within Sponsor/IRB's timeframe and in accordance with site SOP./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Follow SOPs/GCPs/HIPPA according to the site, sponsor, ICH, and FDA./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight, and that the site Regulatory Specialist receives reviewed/corrected/signed copy of the report./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"File appropriate regulatory or Sponsor communications with the site Regulatory Specialist./span/span/span/li lispan style="font-size:11pt;"span style="color:#000000;"span style="font-family:Calibri, sans-serif;"Create and maintain Master Subject Log and Visit Log. /span/span/span /li /ul p /p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice./span/span/p/span/div/div/divdiv class="cl HeadSecondary"h2Qualifications/h2/divdiv aria-label="Qualifications" class="row" name="qualifications" style="word-wrap: break-word;"div class="row form RowStandard" id="job Qualifications-row" div class="form Line"span class="fb Text ignore-global-css" name="job Qualifications"pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Qualifications:/span/strong/span/span/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Minimum High School Diploma or GED required./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Minimum of two (2) years of clinical research experience. /span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI)./span/span/li /ul pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strong Travel:/strong/span/span/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Must have the ability amp; willingness to travel to other sites as necessary within a geographic region./span/span/li /ul pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Knowledge, Competencies amp; Skills:/span/strong/span/span/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Exceptional customer service skills./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Strong attention to detail, a willingness to learn amp; the ability to stay organized./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Ability to perform clinical assessments./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Strong understanding of FDA clinical trial phases I-IV. /span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Strong understanding of GCP set forth by the ICH. /span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Proficient knowledge of medical terminology./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Proficient knowledge of Research related Terminology./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Strong communication skills, both verbal amp; written./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Proficient computer software and database skills./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Comfortable working in a fast-paced environment./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Very comfortable asking probing questions to patients, if applicable./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Must demonstrate a caring, compassionate, and patient attitude./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Maintain HIPAA compliance./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Multitasking and proactive problem-solving./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Ability to type a minimum of 40 words per minute./span/span/li /ul pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strongspan style="color:#000000;"Physical Requirements for the Job:/span/strong/span/span/p ul lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Regularly required to sit 4-7 hours/day and stand 1-3 hours/day./span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Intermittently required to stoop, bend, speak, and listen. /span/span/li lispan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"Frequently lift and or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. /span/span/li /ul pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"strong Equal Opportunity Employer:/strong United Urology Group and its affiliate practices are an equal opportunity employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation./span/span/p pspan style="font-size:11pt;"span style="font-family:Calibri, sans-serif;"The successful candidate(s) for any UUG position will be subject to a pre-employment background check./span/span/p p /p p style="text-align:center;"strongem Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws. Applications for this position are accepted on an ongoing basis until the role is filled. There is no specific application deadline./em/strong/p/span/div/div/div/div

The National Institute of Clinical Research (NICR) is an independent, multi-site clinical trial site management organization (SMO). We deliver and facilitate the highest quality Phase 1 - 4 trial management to our multi-specialty network of physicians. NICR undertakes multiple levels of research and planning necessary for any type of clinical trial. NICR provides sponsors and CROs premium services leading to rapid study site identification, trial placement, site initiation, and successful subject enrollment. With more than 30 years of experience, NICR is recognized as one of the leading research organizations in the nation. We are seeking a highly skilled and motivated individual to join our team as Senior Clinical Research Coordinator (CRC II). The CRC II is responsible for the management and coordination of clinical research studies under the direction of the principal investigator (PI) and clinical research manager. This role involves ensuring compliance with all regulatory requirements, maintaining data integrity, and managing study logistics to support the successful completion of clinical trials. Responsibilities include: Coordinate and manage clinical trials from initiation to completion. Develop and maintain study documents, including protocols, informed consent forms, and case report forms. Ensure studies are conducted by Good Clinical Practice (GCP) guidelines and all applicable regulations. Screen, recruit, and enroll study participants. Obtain informed consent from participants. Schedule and conduct study visits, follow-ups, and assessments. Maintain effective communication with study participants to ensure adherence to study protocols. Administrative Duties (may include, but not limited to): Collect, process, and maintain accurate and complete study data. Enter data into electronic data capture systems and ensure timely data entry. Monitor data quality and resolve data queries. Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other regulatory bodies. Ensure compliance with all regulatory requirements, including reporting adverse events and protocol deviations. Train and mentor junior research staff and clinical research coordinators. Stay current with industry best practices and regulatory changes through ongoing professional development. Clinical Duties: Maintain study-related documentation and records to regulatory requirements. Serve as a liaison between the PI, research team, study participants, and external stakeholders. Coordinate with study sponsors, monitors, and other external parties. Participate in study team meetings and provide regular updates on study progress. Qualifications: Bachelor's degree in a related field (e.g., nursing, life sciences, public health) preferred. Minimum of 2-3 years of experience in clinical research coordination. Must be local to the Orange County area. Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred. Strong knowledge of GCP, FDA regulations, and IRB procedures. Excellent organizational, communication, and interpersonal skills. Proficiency in electronic data capture systems and Microsoft Office Suite. Ability to work independently and as part of a multidisciplinary team. Detail-oriented with strong problem-solving skills. Job Types: Full-Time Benefits: Medical, Dental, Vision, 401K, PTO and Bonuses Work Location Garden Grove, CA Occasional travel to other study locations in the Orange County area. Compensation: $24.00 - $32.00 per hour About National Institute Of Clinical ResearchWith more than 30 years of experience in industry and academic research, NICR participates in the development of innovative and life-saving therapies through its dedication to and focus on clinical research. NICR combines the use of the latest technologies, streamlined clinical operations, and extensive access to a diverse population to deliver the highest quality clinical trials for life-changing therapies. Who We AreFrom our roots in Nephrology, we have expanded into many other specialty fields, including cardiometabolic, infectious diseases, geriatrics, and many other challenging & underserved areas of healthcare. We have dedicated ourselves to providing the highest quality clinical trials to our sponsors, investigators, and study volunteers. We pride ourselves in our collective experience, industry knowledge, and dedication to moving patient health forward.

USD $34.56/Hr. to USD $50.14/Hr.Welcome to CommonSpirit Health Mountain Region: CommonSpirit Health Mountain Region is committed to building healthier communities, advocating for those who are poor and vulnerable, and innovating how and where healing can happen-both inside our hospitals and out in the community. With locations throughout Colorado, Utah, and Kansas, we deliver the same high standard of care to our employees as we do to our patients. Our 20 hospitals, emergency and urgent care centers, home care and hospice, Flight for Life Colorado TM , telehealth and over 240 physician practices and clinics offer endless opportunities! Here, you can grow your career and impact the people in the communities you serve. CommonSpirit Health is one of the nation's largest nonprofit, faith-based health systems, with a team of over 150,000 employees and 25,000 physicians and advanced practice clinicians. CommonSpirit operates more than 2,200 care sites and 140 hospitals, serving some of the most diverse communities across the nation, letting humankindness lead the way. Overview: You have a purpose, unique talents and now is the time to embrace it, live it and put it to work. We value incredible people with incredible skills - but your commitment to a greater cause is something we value even more. This is the heartbeat of our organization and your time will be spent in a supportive, team environment with resources to help you flourish and leaders who care about your success. Responsible for the development, coordination, and administration of the Pre-Hospital Services student clinicians and field internship experiences. Supports Pre-Hospital Services strategies to service the pre Hospital community. Qualifications: In addition to bringing humankindness to the workplace each day, qualified candidates will need the following: + High School Diploma/G.E.D required + Associates Degree Required + Bachelors Degree Preferred + Three years of critical care experience with a focus in emergency medicine/trauma and or pre-Hospital required. + Colorado Registered Nurse Licensure or Paramedic certification Physical Requirements Medium Work - exert/lift up to 50 lbs. force occasionally, and/or up to 20 lbs. frequently, and/or up to 10 lbs. constantly Your Connected Community: We believe in the healing power of humanity and serving the common good through our dedicated work and shared mission to celebrate humankindness. Our Total Reward Offerings: We believe investing in our employees lets them know they truly matter. Your Total Rewards package includes compensation, benefits, retirement, wellness, leave, and other programs. Designed with your well-being in mind, we offer: + Several Medical, Dental, & Vision options. + Spending Accounts including a Dependent Care FSA that can include an employer contribution + Retirement account options with a generous employer match + Tuition Reimbursement + Student Loan Forgiveness, and so much more! View more on our benefits HERE (************************************************************************************************************* . Pay Range: $34.56 - $50.14 / hour Shift: Variable We are an equal opportunity employer.

Job Description Ready to step away from the bedside but still make a meaningful impact? At Boulder Medical Center (BMC), you'll find your next chapter. Join our physician-owned, multi-specialty clinic as a Clinical Coordinator and be part of a collaborative team focused on quality care and outcomes. Gain exposure to a range of specialties—from primary care to dermatology and allergy, and more —while broadening your skills and contributing on a system-wide level. Build your future in healthcare, beyond the bedside. BMC is a local, independent, and physician-owned medical group with over 20 primary and specialty care departments, 90 providers, and 325+ clinical and support professionals. Since our founding by 10 physicians in 1949, we have grown and evolved to meet the needs of Boulder County and beyond. We currently have clinics located in Boulder (2 locations), Louisville, Longmont, and Erie. Summary: Boulder Medical Center (BMC) is seeking a medically trained professional—Medical Assistant (MA), Licensed Practical Nurse (LPN), or EMT—to join our Immunization and Occupational Health team as a Clinical Coordinator. This is a full-time, benefit-eligible position (40 hours/week, Monday-Friday). In this role, you'll focus on coordinating and administering vaccines, monitoring patients for adverse or allergic reactions, responding to emergencies, and ensuring that all emergency equipment and medications are prepared and readily available. Job Perks: Full-time employees are eligible for medical / dental / vision, flexible spending, company-paid life insurance and Short Term Disability (STD) as well as several voluntary benefit options, RTD EcoPass, 401(k), Paid Time Off (PTO) and six (6) paid holidays annually. Part-time employees are eligible for medical / dental / vision, company-paid life insurance, voluntary benefits, RTD EcoPass, 401(k), Paid Time Off (PTO) and holiday pay (if regularly scheduled to work on an observed holiday). Day shift work schedules. Experience working within a multi-specialty group practice with both primary and specialty care clinics. Job Duties: Responsible for staffing and scheduling of nurse visits for routine vaccines for current BMC patients ages 7 and older. This would include vaccination of BMC staff during orientation as needed. Assists in the planning and implementation of the BMC annual vaccine clinics (COVID, flu, etc.), including offering vaccines to BMC patients at the daily clinic and providing vaccines for BMC staff and providers. When performing Vaccine Administer Duties/Responsibilities: Draws up vaccines according to provider's order and manufacturer's instructions. Administers vaccines using safe and proper techniques and a system of double checks to ensure accuracy. Administer vaccinations while complying with all applicable federal, state, and local laws/regulations. Disposes of bio-hazardous waste in the appropriate and prescribed manner. Maintains confidentiality at all times. Inspects medical inventory to ensure appropriate materials and equipment are available to include masks, antihistamine, adrenaline injections, and oxygen; checks expiration dates on medication and syringes and removes any that are out of date; fills oxygen tanks as needed. Receive all clinic supplies including vaccine and transport to and from site. Perform clinic set up and cleanup. Return participant PHI and post clinic documentation in a prompt and timely manner. Return unused clinic supplies in a prompt and timely manner. Perform all other duties and tasks as assigned, which may include resource work for provider offices or pharmacy. Records all medical information and vaccine administration in the patient's electronic medical record (EMR) according to BMC EMR protocol. When Performing Observation Duties/Responsibilities: Provide excellent customer service while putting participants at ease. Monitors patients after vaccination to ensure no life threating reactions are occurring; administers appropriate medical intervention as directed by protocols or other medical authorities. Trained and able to access CIIS database to order and reconcile vaccines as necessary for government programs. Injection training - Under guidance of the Clinical Trainer and Clinical Education Coordinator, serves as a preceptor for new employees' injection training. Vaccine inventory - Assists the Public and Occupational Health Nurse with vaccine inventory tracking and management. Occupational health assistance - Assists the Public and Occupational Health Nurse with new hire orientation and ongoing employee health management projects such as TB assessment, TB skin test placement, n95 Fit testing, and necessary employee vaccines. Good history-taking skills, strong, competent computer skills; accurate and complete documentation skills; good time management and organizational skills. Relate well and communicate with patients, providers, and staff. Able to demonstrate self-direction in establishing priorities and working with little supervision. Education Requirements (one of the following options): Completion of Medical Assistant education. *Certification is not required but preferred. Other completed medical training, education, and proof of active certification is an acceptable substitution of Medial Assistant specific credentials. (Examples include but are not limited to: EMT, Surgical Tech, CNA, etc.). Military medical training and education with supporting documentation is an acceptable substitution of Medial Assistant specific credentials. College graduates with a completed four (4) year bachelor's degree is an acceptable substitution of Medial Assistant specific credentials. *College transcripts must reflect completed health science course work. Please submit a copy of your unofficial college transcripts at the time of applying. Experience: Previous experience as a Medical Assistant (MA) in a clinic setting, preferred The starting hourly pay range for this position is commensurate with experience: $22.88 - $28.60/hour (full pay range is $22.88 - $34.32) Location(s): Boulder, CO

**University of Colorado Anschutz Medical Campus** **School of Medicine | Department of Psychiatry | Division of Addiction Science, Prevention and Treatment** **Job Title: Clinical Research Coordinator (Entry - Senior Level)** #00831714 - Requisition: #36090** **Job Summary:** **Key Responsibilities:** + Assist with the day-to-day operations of clinical trials. + Assist with recruitment and pre-screening of study participants. + Coordinate and run research visits including alcohol and cannabis self-administration and fMRI sessions. + Perform blood draws on research participants and process biological samples in the Department of Psychiatry Addiction Biology Lab. + Coordinate and run community research visits in a mobile pharmacology lab. + Perform data entry and quality assurance reviews on study databases. + Participate in weekly lab meetings with study PI, MD, and research team. **Work Location:** Onsite **Why Join Us:** **Why work for the University?** + Medical: Multiple plan options + Dental: Multiple plan options + Additional Insurance: Disability, Life, Vision + Retirement 401(a) Plan: Employer contributes 10% of your gross pay + Paid Time Off: Accruals over the year + Vacation Days: 22/year (maximum accrual 352 hours) + Sick Days: 15/year (unlimited maximum accrual) + Holiday Days: 10/year + Tuition Benefit: Employees have access to this benefit on all CU campuses + ECO Pass: Reduced rate RTD Bus and light rail service **Equal Employment Opportunity Statement:** **Qualifications:** **Minimum Qualifications:** **Entry Level:** + Bachelor's degree in any field. + A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. **Intermediate Level:** + Bachelor's degree in any field. + A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. + One (1) year of clinical research or related experience. **Senior Level:** + Bachelor's degree in any field. + A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. + Two (2) years of clinical research or related experience. **Preferred Qualifications:** + Bachelor's degree in science or health related field. + Three (3) years of clinical research or related experience. + Phlebotomy certification or equivalent or willing to obtain certification at our expense. + Experience or comfort with handling biohazardous materials such as human blood, urine, and saliva samples. + Experience with REDCap surveys and data entry. + Experience conducting human subjects research visits or eligibility screenings. + A master's degree or higher in a mental health field (i.e., clinical psychology, counseling, social work). + Experience administering structured clinical interviews to research participants. **Conditions of Employment:** + Ability to work evenings and weekends as scheduled. **Knowledge, Skills, and Abilities:** + Knowledge and understanding of federal regulations and Good Clinical Practice (GCP). + Ability to communicate effectively, both in writing and orally. + Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. + Outstanding customer service skills. + Knowledge of basic human anatomy, physiology medical terminology. + Ability to interpret and master complex research protocol information. + Strong organizational skills with the ability to multitask and meet deadlines. + Proficiency in Microsoft Office Suite. **How to Apply:** **Screening of Applications Begins:** **March 3** **rd** **, 2025.** **Anticipated Pay Range:** **Entry Level:** **Intermediate Level:** **Senior Level:** **ADA Statement:** **Background Check Statement:** **Vaccination Statement:** **Qualifications** **Job Category** **Primary Location** **Schedule** **Posting Date** **Unposting Date** **To apply, visit ******************************************************************** (****************************** Copyright 2025 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency (***************************** Clinical Research Coordinator (Entry - Senior Level) - 36090 University Staff The Clinical Research Coordinator will be supporting several different research projects in the School of Medicine, Department of Psychiatry, Division of Addiction Science, Prevention and Treatment at the University of Colorado, Anschutz Medical Campus. This position will support research projects in the TrAIL (Translational Addiction Imaging Lab, (PI: Dr. Joseph Schacht). The primary focus of the TrAIL is developing pharmacological treatments for alcohol and substance use disorders. The successful applicant will have the opportunity to work on several NIH-funded projects, which involve the evaluation of novel medications to treat Alcohol Use Disorder and Cannabis Use Disorder and involve the use of genetic and neuroimaging measures and alcohol administration in the laboratory. This position is an ideal opportunity for a candidate pursuing a career or planning an advanced degree in medicine, public health, clinical psychology, neuroscience, biomedical research, or related fields in the future. - this role is expected to work onsite and is located in Aurora, CO. The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit ****************** (******************************************************* URL=http://******************) . The Department of Psychiatry is one of the largest units in the UCD-SOM and is comprised of 5 Divisions. The CU Department of Psychiatry sets the standard for Education and Training of leaders in psychiatry and mental health care, conducts ground-breaking Research that aims to eradicate suffering due to psychiatric and substance use disorders, provides ready access to state of-the-art mental health preventions and interventions across the continuum of care, and collaborates with the community and other key stakeholders to promote well-being among all Coloradans. We accomplish this vision in a manner that respects, values and advocates for the dignity and worth of each individual and family.We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: There are many additional perks & programs with the CU Advantage (******************************************************* URL=************************** . The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply. Applicants must meet minimum qualifications at the time of hire. For full consideration, please submit the following document(s):1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.Questions should be directed to: Quinton Powell, *************************************** (******************************************************* URL=***************************************) Applications will be accepted until finalists are identified, but preference will be given to complete applications received by Those who do not apply by this date may or may not be considered. The starting salary range (or hiring range) for this position has been established as: $48,446 - $61,623 $52,721 - $67,061 $56,995 - $72,498The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Total Compensation Calculator: ***************************** (******************************************************* URL=*****************************) The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ******************************** (******************************************************* URL=********************************) . The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (******************************************************* URL=*********************************************************************************** . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (******************************************************* URL=************************************************************************************* . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20921 - SOM-PSYCH-SUB-DEP SPG/GIFT : Full-time : May 21, 2025 : Ongoing Posting Contact Name: Quinton Powell Posting Contact Email: *************************************** (******************************************************* URL=***************************************) Position Number: 00831714jeid-ba89e87ca9ecdf4bbf4eb2613c38c692 The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** A Clinical Site Monitor serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Clinical Site Monitor will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: + Site Selection + Pre-trial assessment + Site level Study Participant recruitment/retention plans + Site Activation/Initiation + On-site and remote monitoring + Overall site relationship management in collaboration with other sponsor roles that interact with the site + Close-out activities **Essential Job Responsibilities:** + Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. + Develops meaningful site relationships through consistent collaborative communication and engagement. + May participate in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. + Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. + Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. + Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. + Ensure ongoing adequacy of site (facilities, staff) for trial conduct. + Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA + Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. + Ensures site non-IMP study supplies are adequate for trial conduct. + Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. + Oversees the appropriate destruction of clinical supplies. + Ensures site staff complete data entry and resolve queries within expected timelines. + Ensures validity and completeness of data collected at trial sites. + Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. + Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. + Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. + Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. + Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. + Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. + Prepares trial sites for close out, conduct final close out visit. + Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. + May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. **Quantitative Dimensions:** May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines. **Organizational Context:** Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. **Qualifications:** **Required** + BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience. + 5 years onsite monitoring experience. + A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience. + Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. + Strong critical thinking and problem-solving skills. + Strong IT skills in appropriate software and company systems. + Willingness to travel up to 40% with overnight stay away from home. + Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language. + Good written and oral communication. **Preferred:** + Experience working cross-functionally and in matrix teams + Experience in executing Lead CSM role + Experience mentoring more junior site monitors or site managers + Experience working in early development studies **Salary Range** $122,500K - $175K (NOTE: Final salary could be more or less, based on experience) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Early Development Clinical Operations Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Job Details Lakewood Clinic - Lakewood, CO Full Time High School $26.00 - $31.00 Hourly ResearchDescription Are you interested in making a difference in patient care? Learn about our unique culture of respect, growth, innovation, the best patient care, and how we give back to the community. At United Urology Group , our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care. We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff! We deliver a cohesive approach to urologic care that provides patients access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies. We offer competitive salaries and a great work/life balance: enjoy your weekends! UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more! United Urology Group is regarded as the leading urology network in the country. Our Urology Group Affiliates consist of Chesapeake Urology, Arizona Urology- Phoenix & Scottsdale, Arizona Urology - Tucson, Colorado Urology & Tennessee Urology. Position Summary: The Research Coordinator will screen, enroll, and follow study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are in study. Primary Duties & Responsibilities: Conducting Clinical Trials Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation. Review the protocol and the informed consent form for accuracy and clarity. Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff. Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP). Schedule site Sponsor visits in accordance with internal SOP. Prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory Specialist, when applicable. Ensure maintenance and calibration of site study required equipment. Enrollment of Study Subjects Review the study design and inclusion/exclusion criteria with the PI/SI and, if needed, the Sponsor to ensure understanding. Review, verify, and record/collect all relevant documentation in the subject's medical record needed to confirm study eligibility. Review the protocol, informed consent form, and follow-up procedures with the potential study subjects. Ensure the current approved informed consent is signed before subjects are screened and enrolled. Inform and document notification of the subject's Primary Care Physician of trial participation if approved by the subject. Perform delegated Protocol specific tasks as assigned by Principal Investigator. Ensure that the randomization procedures are followed and documented per protocol guidelines. Document protocol exemptions and deviations as appropriate. Ensure duplication of each for filing in the subject source and with the regulatory specialist. Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOP. Follow-Up Procedures Schedule subjects for follow-up visits, collect subjects' responses to therapy, and interview subjects for adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during the subject visit for any notable medical/medication changes from the last research visit. Review laboratory data and communicate abnormal values to the PI/SI and as needed, primary care provider or specialist if additional medical attention is needed. Assess and document subject compliance and accountability with Investigational Product (IP). Document re-education when appropriate. Communicate with research staff to ensure timely and accurate study drug distribution when applicable. Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved. Record all Adverse Events outlined in protocol and review them with the PI/SI. Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject's primary care physician or specialist. Administrative/Clerical Reporting all Deviations/Adverse/SAE within Sponsor/IRB's timeframe and in accordance with site SOP. Follow SOPs/GCPs/HIPPA according to the site, sponsor, ICH, and FDA. Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications. Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight, and that the site Regulatory Specialist receives reviewed/corrected/signed copy of the report. File appropriate regulatory or Sponsor communications with the site Regulatory Specialist. Create and maintain Master Subject Log and Visit Log. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice. Qualifications Qualifications: Minimum High School Diploma or GED required. Minimum of two (2) years of clinical research experience. Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI). Travel: Must have the ability & willingness to travel to other sites as necessary within a geographic region. Knowledge, Competencies & Skills: Exceptional customer service skills. Strong attention to detail, a willingness to learn & the ability to stay organized. Ability to perform clinical assessments. Strong understanding of FDA clinical trial phases I-IV. Strong understanding of GCP set forth by the ICH. Proficient knowledge of medical terminology. Proficient knowledge of Research related Terminology. Strong communication skills, both verbal & written. Proficient computer software and database skills. Comfortable working in a fast-paced environment. Very comfortable asking probing questions to patients, if applicable. Must demonstrate a caring, compassionate, and patient attitude. Maintain HIPAA compliance. Multitasking and proactive problem-solving. Ability to type a minimum of 40 words per minute. Physical Requirements for the Job: Regularly required to sit 4-7 hours/day and stand 1-3 hours/day. Intermittently required to stoop, bend, speak, and listen. Frequently lift and or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Equal Opportunity Employer: United Urology Group and its affiliate practices are an equal opportunity employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation. The successful candidate(s) for any UUG position will be subject to a pre-employment background check. Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws. Applications for this position are accepted on an ongoing basis until the role is filled. There is no specific application deadline.

University of Colorado Anschutz Medical Campus Department\: School of Medicine | Department of Psychiatry Job Title\: Clinical Research Coordinator (Entry - Intermediate Level) Position\: #00830715 - Requisition\: #35957 Job Summary: The Clinical Research Coordinator will work in the School of Medicine, Department of Psychiatry, Division of Addiction Science, Prevention and Treatment at the University of Colorado, Anschutz Medical Campus. This position will support research projects in the Hopfer Lab, (PI\: Christian Hopfer, MD). The primary focus of the position will be working as a clinical research coordinator on a project in the Rocky Mountain Cannabis Research Center examining the effect of CBD on cannabis use and craving in adults and potentially other clinical trials in the Hopfer Lab and division. Additionally, this position will support projects in the Ellingson Lab, (PI\: Jarrod Ellingson, PhD) that are investigating pain and alcohol use. This project includes a laboratory visit, as well as brief surveys sent to participants' phones for 30 days to assess how their pain and alcohol use fluctuate. The goal of this study is to investigate pathways that lead from pain to alcohol use among individuals with and without chronic pain. This position is an ideal opportunity for a candidate pursuing a career or planning an advanced degree in medicine, public health, clinical psychology, neuroscience, biomedical research, or related fields in the future. Key Responsibilities: Assist with the day-to-day operations of a clinical research studies. Screen, schedule, obtain informed consent, and interview research participants. Coordinate and run community research visits in a mobile pharmacology lab. Perform blood draws on research participants and process biological samples in the Department of Psychiatry Addiction Biology Lab. Perform data entry and quality assurance reviews on study databases. Participate in lab meetings with study PI/MD and research team. Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit ******************* The Department of Psychiatry is one of the largest units in the UCD-SOM and is comprised of 5 Divisions. The CU Department of Psychiatry sets the standard for Education and Training of leaders in psychiatry and mental health care, conducts ground-breaking Research that aims to eradicate suffering due to psychiatric and substance use disorders, provides ready access to state of-the-art mental health preventions and interventions across the continuum of care, and collaborates with the community and other key stakeholders to promote well-being among all Coloradans. We accomplish this vision in a manner that respects, values and advocates for the dignity and worth of each individual and family. Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: Medical\: Multiple plan options Dental\: Multiple plan options Additional Insurance\: Disability, Life, Vision Retirement 401(a) Plan\: Employer contributes 10% of your gross pay Paid Time Off\: Accruals over the year Vacation Days\: 22/year (maximum accrual 352 hours) Sick Days\: 15/year (unlimited maximum accrual) Holiday Days\: 10/year Tuition Benefit\: Employees have access to this benefit on all CU campuses ECO Pass\: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Equal Employment Opportunity Statement: The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply. Qualifications: Minimum Qualifications: Entry Level: Bachelor's degree in any field. Intermediate Level: Bachelor's degree in any field. One (1) year clinical research or related experience. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications: Bachelor's degree in science or health related field. Two (2) years of clinical research or related experience. Experience conducting human subjects research visits or eligibility screenings. Phlebotomy certification or equivalent or willing to obtain certification at our expense. Experience or comfort with handling biohazardous materials such as human blood, urine, and saliva samples. Experience with REDCap surveys and data entry. Knowledge, Skills, and Abilities: Knowledge and understanding of federal regulations and Good Clinical Practice (GCP). Ability to communicate effectively, both in writing and orally. Ability to establish and maintain collaborative and effective working relationships with employees at all levels throughout the institution. Outstanding customer service skills. Knowledge of basic human anatomy, physiology, and medical terminology. Ability to interpret and master complex research protocol information. Strong organizational skills Proficiency in Microsoft Office Suite.

University of Colorado Anschutz Medical Campus School of Medicine | Department of Medicine | Division of Pulmonary Sciences and Critical Care Job Title: RN/RT Clinical Research Coordinator #00832791 - Requisition: #36471 Envision yourself in a collaborative, inclusive, and innovative work environment that has a deep commitment to position our graduates for success in their professional and personal lives. Visualize applying your energy and skills for an organization that respects and cares about its employees enough to offer some of the best benefits of the industry while encouraging every team member to grow, collaborate, and provide input on how to consistently make the workplace a place people love to work. Imagine working at a college that welcomes everyone - students, faculty, staff, and community members - regardless of their backgrounds, beliefs, or traditions. If what was just described is what you look for in a workplace, welcome to the University of Colorado! The Division of Pulmonary Sciences and Critical Care Medicine is seeking an organized individual for a full-time Clinical Research Nurse to assist the Asthma Research Program with both industry and grant-funded clinical protocols. This Registered Nurse or Respiratory Therapist Clinical Research Coordinator position will be responsible for screening, enrollment, study visits, data management, regulatory compliance, and other duties associated with performing clinical research activities. Must have excellent organizational, time management, and communication skills. The successful candidate will be a productive member of the research team and participate in research projects. The candidate should be able to work independently and as a member of a team and have the ability to support several ongoing clinical studies simultaneously. Flexible work hours, including infrequent evening or weekend, may be required. At this time, this position is a hybrid position, with some work being completed in the office and some done remotely. This may change depending on the University guidelines. This position works closely with the Principal Investigators, other research coordinators, and laboratory members in a cooperative environment with growth potential. Key Responsibilities: * Perform clinical visits for asthma studies, including lung function testing, spirometry, methacholine, blood draws. * Take part in recruitment and managing aspects of clinical studies * Follow up with participants throughout study progression * Follow research protocols and manual of procedures * Participate in the regulatory management of study protocols. Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: About the Division of Pulmonary Sciences and Critical Care Medicine Welcome to the Division of Pulmonary Sciences and Critical Care Medicine at the University of Colorado! We are located at Anschutz Medical Campus and are housed in the Department of Medicine under the School of Medicine. Our over 140 faculty are located across four sites: the University of Colorado Anschutz Medical Campus, National Jewish Health, Denver Health, and the VA Eastern Colorado Health Care System. We are very proud of our long and illustrious history. Many seminal discoveries in pulmonary and critical care medicine occurred here in Denver, including advances in tuberculosis, interstitial lung disease, airway disease, cancer, and critical care. Many of our former trainees have taken leadership roles in academic medicine, including Division and Department Chairs, Deans, and American Thoracic Society Presidents. However, we do not rest on our laurels! We continue to enhance all aspects of our division and training program, and as a result, we have seen tremendous and sustained growth. The clinical practice sites have built new hospitals, and there are multiple new research buildings across the campuses. We have been fortunate to recruit tremendous new faculty members while retaining many of our former trainees. About the University of Colorado Anschutz Medical Campus The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit ******************* Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including: * Medical: Multiple plan options * Dental: Multiple plan options * Additional Insurance: Disability, Life, Vision * Retirement 401(a) Plan: Employer contributes 10% of your gross pay * Paid Time Off: Accruals over the year * Vacation Days: 22/year (maximum accrual 352 hours) * Sick Days: 15/year (unlimited maximum accrual) * Holiday Days: 10/year * Tuition Benefit: Employees have access to this benefit on all CU campuses * ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Diversity and Equity: The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment. Qualifications: Minimum Qualifications: * Bachelor of Science in Nursing (BSN) degree. * An Associate Degree in Nursing (ADN) degree and two (2) additional years of experience will substitute for the BSN degree. * Three (3) years of clinical research or relate experience. * Current licensure as a registered nurse. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications: * Four (4) years of clinical research or related experience. * Experience with electronic data capture systems (e.g., EMR or EHR and data management systems). * Experience with phlebotomy. * Experience with developing and conducting clinical trials, including site monitoring strategies and risk mitigation. * Certified Respiratory Therapist. Knowledge, Skills, and Abilities: * Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP). * Ability to communicate effectively, both in writing and orally. * Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. * Outstanding customer service skills. * Demonstrated commitment and leadership ability to advance diversity and inclusion. * Knowledge of basic human anatomy, physiology, and medical terminology. * Ability to interpret and master complex research protocol information. * Knowledge of IRB submissions and regulatory compliance. * Critical thinking skills with decisive judgment. * Ability to work with minimal supervision. * Ability to work in a fast-paced environment and take appropriate action. How to Apply: For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position. 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address. Questions should be directed to: Fernando Holguin, ******************************* Screening of Applications Begins: Immediately and continues until position is filled. For best consideration, apply by April 15th, 2025. Anticipated Pay Range: The starting salary range (or hiring range) for this position has been established as $64,594 - $82,164. The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: ***************************** ADA Statement: The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ********************************. Background Check Statement: The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. Vaccination Statement: CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.