Clinical research associate jobs in Highlands Ranch, CO

University of Colorado Anschutz Medical Campus Department\: Orthopedics Job Title\: Clinical Sciences Entry Professional #\: 00796643- Requisition #\:38350 Job Summary: This Entry Clinical Science Professional (ie\: research assistant) will serve as a Research Coordinator for CU Sports Medicine. CU Sports Medicine is one of the premier sports medicine groups in the Rocky Mountain region with regional, national and international recognition and influence. The clinical group headed by Dr. Eric McCarty are orthopedic sports medicine surgeons as well as non-operative fellowship trained sports medicine physicians from the Family Medicine and PM&R Departments of University of Colorado School of Medicine. The group serves as the team physicians for the Denver Broncos, Denver Nuggets, Colorado Rockies, Colorado Avalanche, Colorado Mammoth, Colorado Rapids as well as the University of Colorado and multiple high schools throughout the front range of Colorado. Their research efforts include mainly the investigation of clinical outcomes on their patients which range from the elite world class athlete to the recreational weekend warrior. Interaction is wide and varied with unique athletes and patients from around the Front Range. Additionally, there is interaction with other sports medicine facilities and researchers across campus as well as across the country which CU Sports Medicine collaborates with on multicenter research efforts. Primary research responsibilities for this position arc focused on orthopedic surgery investigation of the knee and shoulder. The position reports directly to Dr. Jonathan Bravman, though has heavy involvement from several other motivated researchers, including Dr. Rachel Frank, Dr. Adam Seidl and Dr. Michelle Wolcott. Key Responsibilities: Assist with and oversee the day to day operations of clinical trials and studies Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews Travel to various clinics and hospital operating rooms to support performance of clinical trials occasionally required Interface with Industry Representatives to ensure surgical equipment is available/present at surgery for clinical trial execution Collection of surgical tissue samples with preparation and transport to lab for processing Work Location: Onsite - this role is expected to work onsite and is located in Aurora, CO. Why Join Us: The University of Colorado Orthopedic Department is one of the nation's top orthopedic programs, and the University of Colorado Hospital has been ranked the #1 hospital in Colorado 7 years running. The department has a robust research infrastructure and offers extensive opportunities to be a part of high-quality clinical research and participate in cutting-edge projects. Our research continues to advance the field of orthopedics with technological advances and discoveries in orthopedic care. 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. Qualifications: Minimum Qualifications Bachelor's degree in any field from an accredited institution A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis. Preferred Qualifications Bachelor's degree in science or health related field from an accredited institution Clinical research or related experience Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) Competencies, 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 Applicants must meet minimum qualifications at the time of hire. How to Apply: For full consideration, please submit the following document(s): Curriculum vitae / Resume Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to\: Thomas Roller, ****************************. Screening of Applications Begins: Screening begins immediately and continues until December 19, 2025. Anticipated Pay Range: The starting salary range ( or hiring range ) for this position has been established as HIRING RANGE $48,446 - $61,623 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 Equal Employment Opportunity Statement: CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination 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, including protected veterans and individuals with disabilities. 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.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What You Will Be Doing:** + Serve as the primary point of contact between investigational sites and the sponsor + Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation in CTMS and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting + Support subject recruitment and retention efforts at the site level + Oversee drug accountability and ensure proper storage, return, or destruction + Resolve data queries and drive timely, high-quality data entry + Document site progress and escalate risks or issues to the clinical team + Assist in tracking site budgets and ensuring timely site payments (as applicable) + Collaborate with cross-functional partners including CTAs, LTMs, and CTMs **You are:** + A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN + Eligible to work in United States without visa sponsorship + A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry + Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology + Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF + A clear communicator, problem-solver, and collaborative team player + Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (AZ, CO, CA, UT) near major HUB airports to support efficient regional travel **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 maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. 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, color, 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 or submit a request here (****************************************************** 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. Are you a current ICON Employee? Please click here (****************************************************** to apply

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 Clinical Research Associate - Cardiovascular At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients! About the Position: Edgewise is headquartered in Boulder, Colorado; this is a position for a growing Colorado-based Clinical Development team. The assigned clinical trials will be highly complex and high risk, e.g. multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidates may be asked to provide support to the Edgewise clinical study lead for more than one study or across programs. Key Responsibilities: Lead site start-up activities (e.g. oversight of CRO start-up activities, accountable for essential document package review, site initiation slide deck, vendor training, participate in remote/or on-site initiation visits) and contribute to feasibility, as required. Collaborate with contracts team to lead review and negotiation of site and vendor budgets/contracts. Contribute to the development and review of study, patient and site facing documents (e.g. protocols, ICFs and study plans). Oversee Edgewise contract CRA and/or CRO monitoring activities (e.g. visit schedules, monitoring visit reviews, monitoring plan review). May include on-site co-monitoring with CRO CRA, ensuring compliance with protocol and regulatory requirements. Provide additional clinical monitoring training support to CRO personnel, as needed. Attend CRO monitoring meetings. May include assigned monitoring responsibilities for sites. Review and oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits. Support the Edgewise clinical study lead in managing progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment and other tasks as assigned. Proactively review electronic data capture (EDC) for completion and to identify issues and generate queries. Identify and monitor risks and decisions at the study level and implementation of mitigation strategies. Identify potential operational challenges, and in collaboration with senior team members, provide guidance and solutions to ensure study execution remains on track. Contribute to drafting Standard Operating Procedures (SOPs) and adhere to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections. Responsible for the oversight of assigned vendors. Collaborate with internal teams (e.g. Clinical Operations, Regulatory Affairs, Data Management, Medical Monitoring, CMC, etc) to ensure seamless trial execution and provide regular study updates to the appropriate internal stakeholders. May be accountable for reviewing site or vendor invoicing and financial management in accordance with the clinical trial agreement / scope of work. Support TMF activities as required (e.g. review of TMF index, document provision, etc.). Support onboarding and mentoring of new department members. Required Education, Experience, Skills: At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences) Minimum 4 years of independent on-site monitoring experience (across all visit types and inclusive of remote monitoring), with at least 3 years cardiac study experience in a pharmaceutical sponsor environment preferred (global pharma or biotech preferred). Excellent attention to detail, verbal, written, interpersonal and presentation skills are required Must be familiar with routine medical/scientific terminology; Proficiency with MS Office required (inclusive of PPT); Smart Sheet proficiency desirable Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is required Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision Highly productive, engaged and accountable Team-player desiring to work in a fast-moving, dynamic start-up environment This is a full-time position (40 hours/week), hybrid, Colorado based preferred. 20-50% travel. Salary range: $100,000 - $140,000, title and salary commensurate with experience Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan. There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

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.

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities Leads a team of clinicians and technicians in carrying out complex study protocols: o Management may include multiple concurrent studies o Studies may require multiple visits by participants o Studies may require travel to other states Responsible for understanding protocol requirements and utilizing critical thinking skills Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals Creates case report forms, based on written protocol Develops, completes, and maintains source documents Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols Assures clinical supply accountability for assigned trials Responsible for securing all sponsor-supplied devices and equipment Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training Must not have any disciplinary action on license history Clinical Research Experience preferred Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred Strong organizational and critical thinking skills, including attention to detail Travel is required up to 25% Must be capable of performing all clinical tasks relevant to licensure and/or training Must possess excellent written and verbal communication skills Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company Technical background is a plus #LI-TK1 Company Overview Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world's most trusted testing partner”. All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) “If you need an accommodation filling out an application, or applying to a job, please email ***********************”

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities * Leads a team of clinicians and technicians in carrying out complex study protocols:o Management may include multiple concurrent studieso Studies may require multiple visits by participantso Studies may require travel to other states * Responsible for understanding protocol requirements and utilizing critical thinking skills * Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals * Creates case report forms, based on written protocol * Develops, completes, and maintains source documents * Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File * Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols * Assures clinical supply accountability for assigned trials * Responsible for securing all sponsor-supplied devices and equipment * Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. * Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. * Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications * Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred * Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training * Must not have any disciplinary action on license history * Clinical Research Experience preferred * Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred * Strong organizational and critical thinking skills, including attention to detail * Travel is required up to 25% * Must be capable of performing all clinical tasks relevant to licensure and/or training * Must possess excellent written and verbal communication skills * Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. * Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) * Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company * Technical background is a plus #LI-TK1 Company Overview Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner". All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) "If you need an accommodation filling out an application, or applying to a job, please email ***********************"

Element has a current opening for a Clinical Research Manager to join our growing team in Louisville, CO for a full time position. The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians. You can learn more about the lab here: EMT Louisville CO Lab Page Pay Range: $100k-$145k DOE Responsibilities Leads a team of clinicians and technicians in carrying out complex study protocols: o Management may include multiple concurrent studies o Studies may require multiple visits by participants o Studies may require travel to other states Responsible for understanding protocol requirements and utilizing critical thinking skills Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals Creates case report forms, based on written protocol Develops, completes, and maintains source documents Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols Assures clinical supply accountability for assigned trials Responsible for securing all sponsor-supplied devices and equipment Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish. Has the ability to directly supervise employees that perform data analysis and clinical execution. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Skills / Qualifications Must be a Registered Nurse with a current license in the state of Colorado. BSN preferred Ability to independently perform and also train all procedures (i.e. vital signs, laboratory tests, etc.) required by the protocol and as allowed by level of licensure and/or training Must not have any disciplinary action on license history Clinical Research Experience preferred Ability to lead a team with clear direction, responsible delegation, goal-setting, and performance management; prior management experience preferred Strong organizational and critical thinking skills, including attention to detail Travel is required up to 25% Must be capable of performing all clinical tasks relevant to licensure and/or training Must possess excellent written and verbal communication skills Must have good interpersonal skills, demonstrated through interactions with participants, Element staff, sponsor representatives, etc. Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook) Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company Technical background is a plus #LI-TK1 Company Overview Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today'. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world's most trusted testing partner”. All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) “If you need an accommodation filling out an application, or applying to a job, please email ***********************”

National Jewish Health is seeking a skilled and visionary Director of Clinical Research Services to oversee the Clinical Research Services Office and drive institutional success in advancing clinical research. This leadership role is instrumental in fostering collaboration, ensuring regulatory compliance, and developing innovative approaches to enhance research operations. Why National Jewish Health? Top Respiratory Hospital: Recognized as a leader in respiratory care and research, National Jewish Health is home to passionate physicians and staff dedicated to finding effective treatments for chronic and life-threatening diseases. Collaborative Environment: The centrally located clinical research unit promotes strong interdepartmental relationships and direct engagement between physicians and research participants. Opportunity for Impact: This role offers the chance to shape the future of clinical research at a globally recognized institution. The successful candidate will bring expertise in clinical research operations, a strategic mindset, and a proven ability to lead within complex regulatory environments. A commitment to advancing innovation in a collaborative, mission-driven environment is essential. With a 125-year history of groundbreaking care and discovery, National Jewish Health offers the opportunity to lead transformative clinical research that impacts lives worldwide. Position Summary Manages the Clinical Research Services Office and staff and provides leadership in support of institutional, department and faculty goals related to the conduct of clinical research. Essential Duties Manages and develops an effective staff: providing effective communication, leadership, guidance and resources. Determines staff qualifications and competency: recruits, interviews, selects, hires, trains, orients, mentors, evaluates, coaches, counsels, disciplines, and rewards. Establishes and monitors staff safety and regulatory compliance. Serves as liaison between Principal Investigators and clinical research resources. Builds relationships with faculty and staff to enhance and grow the clinical research enterprise at National Jewish Health. Assures the allocation, sharing and efficient utilization of clinical research resources while ensuring quality and consistency. Assures compliance with all applicable regulatory requirements for FDA regulated clinical research. Oversees uniform application of clinical research systems, policies and procedures across all clinical research areas. Acts as a liaison among research managers, both clinical and administrative, to assure optimization of clinical research for the institution. Establishes new business partnerships and maintains existing ones. Works with investigators, sponsors, community members, and internal team members to optimize study processes and enrollment. Initiates and maintains contact with pharmaceutical companies regarding ongoing and future studies. Conducts prequalification visits with sponsor representatives ensuring that studies are conducted and coordinated well and in accordance with sponsor Standard Operating Procedures, FDA regulations and ICH/GCP Guidelines. Directly oversees projects assigned to the research unit including start-up, implementation and close-out. Ensures prompt start-up, efficient and compliant implementation and orderly close-out. Works with the Manager of Clinical Research Finance & Systems in developing budgets that are fiscally sound and inclusive of all potential expenses. Interfaces with internal and external clinical resources to determine pricing. Ensures financial viability of Clinical Research Services program Works with Research Regulatory Affairs to ensure timely IRB submission and regulatory compliance. Develops programs to maximize subject recruitment at both the institutional and project level. Creates, updates, and manages research unit policies and procedures demonstrating an in-depth understanding of FDA and IRB Regulations and ICH/GCP Guidelines. Institutes policies that are compliant with ICH/GCP regulations and guidelines, as well as institutional policies and procedures. Assures adequate functioning of research unit equipment necessary for clinical research. Serves as the unit representative to the FDA and assists FDA and Investigators during FDA audits. Manages the institutional FDA competency program. 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. Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures. Building Strategic Relationships: Identifying opportunities and taking action to build strategic relationships between one's area and other areas, teams, departments, units, or organizations to help achieve business goals. Business Acumen: Using economic, financial, market, and industry data to understand and improve business results; using one's understanding of major business functions, industry trends, and own organization's position to contribute to effective business strategies and tactics. Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences. Impact and Influence: Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations, and individuals involved. Taking advantage of opportunities to make a difference and have an impact. When used well, the intended outcome of this competency is the creation of goodwill, trust, and respect while motivating people to want to follow you even when they don't have to. Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message. Managing Conflict: Dealing effectively with others in an antagonistic situation; using appropriate interpersonal styles and methods to reduce tension or conflict between two or more people. Addresses conflicts by focusing on the issues at hand to develop effective solutions when disputes or disagreements occur; helps others resolve conflicts by providing impartial mediation when needed. Talent Management for Leaders: Clearly establishes and communicates expectations and accountabilities; monitors and evaluates performance; provides effective feedback and coaching; identifies development needs and helps employees address them to achieve optimal performance. Supervisory or Managerial Responsibility Manages 10-20 employees. 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. 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 Biology, Chemistry, Behavioral Science, Science, Health, or Nursing required. Work Experience: A minimum of seven (7) years of recent and related clinical research experience with at least two (2) years' experience in FDA-regulated research and 2 years' experience at the management level. Special Training, Certification or Licensure: Current Clinical Research Coordinator or Clinical Research Associate Certification preferred. Salary Range: $135,674.89 - $179,430.05 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. Visa sponsorship is not available for this position. Applicants must be legally authorized to work in the United States without the need for employer sponsorship, now or in the future. Anticipated Application Deadline: 2025-10-10

Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Clinical Research Manager (RN) at our Midtown location. Bring your established Oncology and or Research experience and join a team dedicated to providing an excellent experience to patients. We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It's much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment. No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient's hand, or a scheduler on the phone finding an appointment that fits into a patient's schedule, we are deeply connected to our patients and do what we can to help. If this sounds like you, we'd love to have you join our team. Salary Range: $110,000-$145,000.00 Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential for research bonus depending on financials of department after one year of employment; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance. A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis. Responsibilities * Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. * Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice. * Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, and progressive discipline. * Enforces adherence to company policies. * Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action plans designed to improve practice research operations and quality assurance functions. * Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. * Develops accountability standard to ensure that targets and budgets are achieved. * Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program. * Responsible to promote or market research program to the practice, community and referring physicians. * Responsible for coordinating research activities with other (non-USOR) bases or sponsors. Qualifications Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred. Business Experience: * Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology * Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred If required for state of practice, current licensure as a registered nurse (RN) SoCRA or ARCP certification preferred Specialized Knowledge/Skills * Excellent communication skills, strong ability to multitask Strong interpersonal skills Must be able to work in a fast paced constantly changing environment Knowledge and proficiency in all basic computer programs, windows, excel etc. * Special knowledge of GCP and ICH guidelines Specific knowledge of all aspects of clinical research * Ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions * Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails * Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements: Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.) All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire. Candidates will be required to show proof of being vaccinated against influenza upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law. This job posting will remain open until we have identified an adequate applicant pool. Applicants are strongly encouraged to apply early.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process Pay range $29.33/hr - $35.00/hr About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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.

Posting TitleSenior Electric Grid Cybersecurity Researcher . . TypeRegular . Hours Per Week40 . Working at NLRNLR is located at the foothills of the Rocky Mountains in Golden, Colorado is the nation's primary laboratory for energy systems research and development. Join the National Laboratory of the Rockies (NLR), where world-class scientists, engineers, and experts are accelerating energy innovation through breakthrough research and systems integration. From our mission to our collaborative culture, NLR stands out in the research community for its commitment to an affordable and secure energy future. Spanning foundational science to applied systems engineering and analysis, we focus on solving complex challenges to deliver advanced, secure, reliable, and cost-effective energy solutions. Our work helps strengthen U.S. industries, support job creation, and promote national economic growth. At NLR, you'll find a mission-driven environment supported by state-of-the-art facilities, multidisciplinary research teams, and strong collaborations with industry, academia, and other national laboratories. We offer robust professional development opportunities, and a competitive benefits package designed to support your career and well-being. Job Description The Cybersecurity Threat Analysis Group (CTAG) within the National Laboratory of the Rockies (NLR) Cybersecurity Research Center performs research to make cybersecurity an enabling part of the nation's energy ecosystem. This is primarily accomplished through engaging with energy sector partners, government program offices, and national security organizations. Research areas within CTAG includes energy system modeling and simulation, threat to consequence risk analysis, and hardware & software supply chain security. CTAG is seeking an experienced senior electric grid cybersecurity research professional to lead our Energy Threat Analysis Center (ETAC) portfolio of work. The ETAC is an operational collaborative that convenes experts from the U.S. Department of Energy and the U.S. energy sector to collectively identify, analyze, and mitigate cyber threats to America's critical energy infrastructure. The successful candidate will bring a combination of strong technical security background and power systems engineering. This role also requires proficiency in developing and executing cybersecurity research within a laboratory environment, knowledge of cutting-edge adversarial Tactics, Techniques, and Procedures, experience leading complex cybersecurity programs across a matrixed organization, a passion for leading and driving new research, and the ability to collaborate with partners from across the national laboratory complex, the Department of Energy, industry, and national security partners. Responsibilities include: Provide technical leadership supporting multi-partner programs, coordinating with program office leadership, tasking and mentoring staff in support of program objectives Lead adversarial research initiatives targeting energy sector systems, including threat emulation, cyber range experimentation, and model-based simulation, defining experimental objectives and strategies Independently design, execute, and evaluate complex adversary-defender studies, including multi-stage attack-chain modeling, vulnerability exploration, and defense validation, ensuring reproducible and rigorous research outcomes Proven leadership in offensive cybersecurity research and program management, including planning and executing complex experiments with strategic impact Advanced proficiency in Python, PowerShell, C/C++, or other languages, enabling automation, data-driven analysis, and modeling integration across projects Expert-level knowledge of ICS, OT, and energy sector systems, including protocols, architectures, and security considerations Writing high-quality intelligence assessments and briefings for both senior-level and technical audiences Contribute specialized knowledge to collaborative response efforts based on cyber incidents Provide technical thought-leadership by proposing and leading new areas of work Support quick reaction tasking requiring research into areas of government concern Serve as a Subject Matter Expert (SME) in adversarial TTPs, cybersecurity mitigations, best practices, and reverse engineering Serve as a SME within our growing supply chain security portfolio of work Collaborate with fellow researchers, Department of Energy staff as well as industrial partners to ensure research relevance and impact . Basic QualificationsRelevant PhD and 9 or more years of experience . Or, relevant Master's Degree and 12 or more years of experience . Or, relevant Bachelor's Degree and 14 or more years of experience . Applies advanced scientific technical principles, theories and concepts. Contributes to the development of new principles and concepts. Considered a national subject matter expert. Demonstrates leadership in a number of areas, including all team, task and/or project lead responsibilities. Demonstrated management of complex and/or impactful projects. Excellent technical writing, interpersonal and communication skills. * Must meet educational requirements prior to employment start date. Additional Required Qualifications Must be able to obtain and maintain a DOE security clearance at the Q/TS/SCI level. Eligibility requirements: To obtain a clearance, an individual must be at least 18 years of age; U.S. citizenship is required except in very limited circumstances. See DOE O 472.2A for additional information. Polygraph may be required. Knowledge of and demonstrated experience in power systems engineering principles and practices Demonstrated experience leading cybersecurity programs for national security partners Demonstrated experience in adversarial cybersecurity practices (e.g., red teaming, reverse engineering, threat hunting) Demonstrated experience with threat hunting or detection engineering Experience deploying and configuring operational technology system components (e.g., SCADA RTUs, PLCs, and HMI) Familiarity with applicable security frameworks, best practices and guidance as provided by IEC62443, NERC CIP, NIST and IEEE Understanding of MITRE ATT&CK for ICS to develop real-world security test strategies Excellent leadership, communication, problem solving and project management skills Strong writing and public speaking skills demonstrated through proposals, presentations, business development and/or customer engagement Preferred Qualifications . Job Application Submission Window The anticipated closing window for application submission is up to 30 days and may be extended as needed. Annual Salary Range (based on full-time 40 hours per week) Job Profile: Researcher V / Annual Salary Range: $140,900 - $253,600 NLR takes into consideration a candidate's education, training, and experience, expected quality and quantity of work, required travel (if any), external market and internal value, including seniority and merit systems, and internal pay alignment when determining the salary level for potential new employees. In compliance with the Colorado Equal Pay for Equal Work Act, a potential new employee's salary history will not be used in compensation decisions. Benefits SummaryBenefits include medical, dental, and vision insurance; short*- and long-term disability insurance; pension benefits*; 403(b) Employee Savings Plan with employer match*; life and accidental death and dismemberment (AD&D) insurance; personal time off (PTO) and sick leave; paid holidays; and tuition reimbursement*. NLR employees may be eligible for, but are not guaranteed, performance-, merit-, and achievement- based awards that include a monetary component. Some positions may be eligible for relocation expense reimbursement. Limited-term positions are not eligible for long-term disability or tuition reimbursement. * Based on eligibility rules Badging RequirementNLR is subject to Department of Energy (DOE) access restrictions. All employees must also be able to obtain and maintain a federal Personal Identity Verification (PIV) card as required by Homeland Security Presidential Directive 12 (HSPD-12), which includes a favorable background investigation.Drug Free Workplace NLR is committed to maintaining a drug-free workplace in accordance with the federal Drug-Free Workplace Act and complies with federal laws prohibiting the possession and use of illegal drugs. Under federal law, marijuana remains an illegal drug. If you are offered employment at NLR, you must pass a pre-employment drug test prior to commencing employment. Unless prohibited by state or local law, the pre-employment drug test will include marijuana. If you test positive on the pre-employment drug test, your offer of employment may be withdrawn. Submission Guidelines Please note that in order to be considered an applicant for any position at NLR you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application. . Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard basis of age (40 and over), color, disability, gender identity, genetic information, marital status, domestic partner status, military or veteran status, national origin/ancestry, race, religion, creed, sex (including pregnancy, childbirth, breastfeeding), sexual orientation, and any other applicable status protected by federal, state, or local laws. Reasonable Accommodations E-Verify ******************** For information about right to work, click here for English or here for Spanish. E-Verify is a registered trademark of the U.S. Department of Homeland Security. This business uses E-Verify in its hiring practices to achieve a lawful workforce.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full-time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Compensation: $28.00 - 31.00/hr (Depending on education, experience, and skillset) Shift: Monday-Friday 08:00 am - 4:30 pm Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the Clinical Research field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

GENERAL DESCRIPTION The Clinical Research Coordinator will be responsible for the oversite of research projects. In addition, the Clinical Research Coordinator must be able to provide efficient services to our physicians as well as provide quality, courteous and compassionate services to our patients in adherence to the guidelines, policies and procedures set forth by Urology Associates. ESSENTIAL JOB FUNCTIONS Develop the research department in scope, size, reputation and professionalism. Assist with the recruitment of studies, budget evaluation and negotiation, protocol evaluation and communication with study sponsors. Maintain certifications in, and continually update knowledge of FDA, GCP, ICH, federal and state regulations, etc. Obtain and maintain patient consent with the highest ethical standards. Work with staff including management in a leadership role in areas such as training, delegating responsibilities, etc. Work directly with patients for screening, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc. Communicate with and support patients and their families as necessary. Work with the EMR and data management systems to complete EDC, eCRFs, locate patients and maintain records. Must have the ability to gain knowledge of relevant software and programs. Have a basic and working knowledge of trial design, statistical methods, etc. Triage, record and report adverse events. Record and report any protocol deviations. Work closely with IRB and study sponsors, PIs and Sub-Is. Attend meetings and calls. Create and maintain department SOPs, NDAs, CVs, certifications, etc. Evaluate, purchase and maintain necessary equipment. Maintain study budgets and monitor invoicing, billing, and payments. Participate in site visits, SIVs, monitoring, etc. Complete necessary study close-out steps and documentation. Communicate regularly with supervisor, keeping him/her apprised of all pertinent information and providing feedback. Ensure compliance for all regulatory requirements including OSHA, CLIA and HIPAA; immediately and accurately document and report occurrences to supervisor; and ensure compliance with all legal and regulatory requirements as outlined in the corporate compliance plan. Support and adhere to all company policies, procedures and management decisions; maintain confidentiality of patients' medical information; and all confidential administrative related issues. Demonstrate dependability in attendance, punctuality in reporting for work and initiative in completing a full work schedule; meeting or exceeding all established deadlines and utilizing all resources and supplies efficiently and appropriately. Demonstrate the ability to concentrate during the course of the day. Display a positive outlook with a helpful, constructive manner when working with other employees. Demonstrate superior patient relations and interpersonal skills; demonstrate an appropriate level of mental and emotional tolerance and even temperament when dealing with staff, patients and general public using tact, sensitivity and sound judgment; promote a positive work environment and contribute to the overall efforts of the department and the company. OTHER DUTIES Assist in performing special projects and other related duties as assigned or directed by CPC physicians and Administrative staff. Complete other tasks as assigned. POSITION REQUIREMENTS Must have knowledge of and experience with relevant federal and state regulatory guidelines. Must have a minimum of two (2) years of experience with conducting clinical trials. Urology based clinical experience is preferred. Experience with evaluating and implementing study protocols and budgets. Certification by ACRP or an equivalent is preferred. Proficiency in computer software to include Microsoft Office, EMR and Practice Management systems. Ability to plan, schedule, prioritize and complete multiple tasks and demands is required Excellent oral and written communication, interpersonal, problem-solving and organizational skills are required. Occasional overtime, evening and weekend work is required. A valid driver's license, dependable automobile and current auto insurance are required for occasional travel for business purposes and to work at satellite locations. ESSENTIAL PHYSICAL REQUIREMENTS Requires prolonged sitting and standing, some bending, stooping and stretching, or performing other work requiring moderate physical exertion. Capacity to maintain physical activity over prolonged periods of time (stamina). Able to see for the purpose of reading information received in different formats including but not limited to paper, computer, reports, bulletins and manuals. Able to hear for work-related purposes. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Able to lift up to a minimum of 25 pounds. ESSENTIAL ENVIRONMENTAL CONDITIONS Work is generally performed under normal office working conditions. Normal level of visual strain. Ability to cope with stress caused by public in

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Research Treatment Nurse for the Drug Development Unit your primary responsibility is to treat and manage patients enrolled on clinical trial. You will closely follow study patient(s) throughout treatment course ensuring protocol compliance You will administer chemotherapy as ordered by physicians You will read and interpret EKGs Must communicate all protocol related issues/problems to the investigator You will assess patient for side effects of treatment and symptoms related to disease or disease progression You will assess lab data and communicates abnormal findings to the investigator and oncologist You will assess and document patient compliance with medications and return visits You will communicate with the pharmacy staff to provide timely and accurate study drug distribution You will maintain a current medication list and records in protocol specific requirements You will provide data team with completed follow-up forms, medical records, lab data and other source documents in a timely manner You will educate and orient ancillary staff in study specific procedures You will document and report adverse events You will perform telephone triage Assesses the patients EMR to ensure that all required data has been entered prior to patients scheduled appointment You will perform patient counseling and referral to appropriate support services You will monitor schedules daily for appropriate treatment distribution and additional patient visits You should have for this position: An Associate Degree; preferably a Bachelor's Degree Current licensure in the state of Colorado as a Registered Nurse Knowledge of medical and research terminology Knowledge of FDA Code of Federal Regulations and GCP Knowledge of the clinical research processes Knowledge of Phase I protocol One year of acute care nursing experience required At least on year of oncology experience preferred At least one year of experience in a research setting preferred Current BLS certification Current ACLS certification (can complete within nine months of start date) ONS Chemotherapy Provider card (can complete within nine months of start date) Research Certification (ACRP or CCRP) Preferred The salary range for this position is: $83,000 - $100,000 annually About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Description We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field or equivalent experience. At least 1-2 years of experience in clinical research preferred. Phlebotomy certification or MA certification preferred. Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials, especially in a hospital or academic setting. Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus. Job Type: Full-time Work Location: In person Schedule: 8 hour shift Monday to Friday Weekends as needed