Clinical research coordinator jobs in Golden, CO - 68 jobs

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 ***********************”

Clinical Research Point Coordinator - Open Rank Intermediate to Senior - 37346 University Staff Description University of Colorado Anschutz Medical CampusDepartment: Clinical Research Support Team (CReST) Job Title: Clinical Research Point Coordinator - Open Rank Intermediate to SeniorPosition #: 00827546 - Requisition #: 37346Job Summary:The Clinical Research Support Team (CReST) has an opening for a full-time Point to Senior Clinical Research Coordinator to provide regulatory, study coordination, and data collection/entry support for a variety of drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals. This position may act as lead or co-lead coordinator overseeing coordinating activities for assigned studies, and/or as a primary contact for training and guidance for junior coordinators supporting these studies. This position will have independent decision making and project management responsibilities. Knowledge of Good Clinical Practice and Good Documentation Practices in the context of clinical research is essential. We are seeking an individual who is collaborative, communicative, caring, detail oriented and organized, proactive, able to think critically, focused on quality, passionate about research, dedicated to personal growth, and highly motivated in all areas of study coordination. Key Responsibilities:Point level -Shepherds and completes study startup activities from initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation to prepare completely for enrollment of the first study subject. Proactively seeks guidance and engages stakeholders to problem solve and push forward startup activities efficiently to meet sponsor timelines. Delegates startup tasks to other assigned team members and/or leadership to efficiently execute and meet timelines and milestones. Independently crafts and submits nursing orders for approval Modifies, or supervises modifications of Informed Consent Forms to comply with Institutional guidelines and obtains required approvals Completes and manages regulatory submissions to local and central IRBs, PRMS, and other regulatory bodies. Drafts regulatory documents and completes forms/paperwork. Fields questions and provides study-specific updates related to regulatory submissions and progress Trains and mentors junior staff, and serves as a reference point within CReST for questions and guidance related to their duties and assigned studies. Develops protocol-specific systems and documents including process flows, training manuals, source documents, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Demonstrates and applies comprehensive working knowledge of applicable regulations, policies and GCP, and advises coworkers and study teams on compliance and application. Assists senior staff with more advanced tasks Provides feedback to CReST managers and leadership on billing and invoicing systems and related metrics. Senior level only - All entry and mid-level duties Advises investigators on regulatory matters, best practices, and institutional policies. May develop or assist with development of research plans. Engages with essential research resource teams on campus, including UCHealth Research Admin, OnCore, pharmacies, labs, and clinics for study planning. Develops working relationships with key contacts to strategize on study startup and implementation. Independently project-manages full-service study startup. Negotiates Study Startup Agreements. May present on behalf of CReST or studies at University or external events Oversees study closeout and archiving activities Serves as a strategic partner and advisor to CReST leadership on development and implementation of SOPs and other standard work. Consult as needed with CReST leadership on the activities, status, metrics, and capabilities of the CReST coordinator program. Undertakes special projects in collaboration with teams, supervisors and/or leadership in creating and implementing processes and procedures and quality improvement initiatives related to CReST operational efficiency and the coordinator program. This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority. Work Location:Hybrid - this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings. Why Join Us:The Clinical Research Support Team (CReST) is part of Office of the Vice Chancellor of Research (OVCR). CReST provides a la carte support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients. 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, VisionRetirement 401(a) Plan: Employer contributes 10% of your gross pay Paid Time Off: Accruals over the year Vacation Days: 22/year (maximum accrual 352 hours) Sick Days: 15/year (unlimited maximum accrual) Holiday Days: 10/year Tuition Benefit: Employees have access to this benefit on all CU campuses ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage. Equal Employment Opportunity Statement: 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. Qualifications:Minimum Qualifications:A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 1 year of professional level experience working in human subjects' research. Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications:Previous experience with software programs such as REDCap, OnCore and EPIC are preferred. Experience with University of Colorado Anschutz and/or affiliated Hospital (e. g. , UCHealth, CHCO) policies and procedures is preferred. Experience with electronic data capture systems (e. g. EMR or EHR and data management systems) Experience with study startup and implementation Clinical research drug and/or device study coordination experience Lab and sample collection and processing experience Research training: CITI, GCP, IATA, blood borne pathogens, Basic Life Support (BLS) Experience completing routine clinical research tasks and documentation, such as conducting informed consent or assessing eligibility Experience with NIH grant-funded research Point LevelA bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution One (1) year of clinical research or related work experience, including experience with interventional trials Senior LevelA bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution Two (2) years of clinical research or related work experience, including experience with FDA-regulated trials Industry-sponsored trials Experience with study startup and/or feasibility assessment ACRP or SoCRA certification (must be obtained within 6 months of date of hire) A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Knowledge, Skills and Abilities:Demonstrated tenacity and initiative in proactively problem solving Ability to interpret and master complex research protocol information Respect for patient rights and dedication to patient safety and protections; excellent patient rapport Empathetic to patients with chronic illnesses Great attention to detail and quality Ability to work with colleagues and patients in a confidential and professional manner Ability to follow and execute a study protocol and proactively prevent deviations Ability to follow direction of the PI and direct supervisor, follow all department SOPs and department policies Critical thinking and sound judgement Outstanding organizational and time management skills Ability to communicate effectively, both in writing and orally. Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. Outstanding customer service skills. Demonstrated commitment and leadership ability to advance diversity and inclusion. Conditions of Employment:At the Senior level, ACRP or SoCRA certification must be obtained within 6 months of date of hire How to Apply:For full consideration, please submit the following document(s):A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position (only use if a cover letter is necessary) Curriculum vitae / ResumeThree to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: John Sorrentino, John. Sorrentino@cuanschutz. edu Screening of Applications Begins:Immediately and continues until position is filled. For best consideration, apply by August 4, 2025. Anticipated Pay Range:The starting salary range (or hiring range) for this position has been established as Point (intermediate): $52,721- $67,061Senior: $56,995 - $72,498The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: *********** cu. edu/node/153125ADA 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 hr. adacoordinator@cuanschutz. edu . 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. Application Materials Required: Cover Letter, Resume/CV, List of References Job Category: Research Services Primary Location: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 21977 - ADM AVC CReST Schedule: Full-time Posting Date: Dec 19, 2025 Unposting Date: Ongoing Posting Contact Name: John Sorrentino Posting Contact Email: John. Sorrentino@cuanschutz. edu Position Number: 00827546

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.

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 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 ***********************”

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.

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

Department: MCR MCR Research (Trauma/Critical Care/Multidisciplinary) FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $24.11 - $36.17 / hour. Pay is dependent on applicant's relevant experience Summary: Coordinates the administrative and clinical aspects of research projects. Responsibilities: + Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols. Monitors and reports on progress of projects as necessary. + Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Performs specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. + Coordinates with investigator to manage adverse events, compliance and other participant-related issues. Facilitates the education of necessary parties such as participants, sponsors and clinicians involved in service delivery. + Implements and oversees the study's compliance with applicable regulations and standards. Assists with responding to and preparing for audits. + Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action. Requirements: + Bachelor's degree. + 2 years of experience coordinating clinical research studies and clinical trials, or 2 years of experience in data management and knowledge of IRB clinical research application procedures. + BLS through the American Heart Association or the American Red Cross CPR for the Professional Rescuer with card in-hand before start date. BLS or CPR card must be good through sixty days of hire. Preferred: + Comfortable in the ER, Inpatient settings and with seeing full traumas + Experience with data studies We improve lives. In big ways through learning, healing, and discovery. In small, personal ways through human connection. But in all ways, we improve lives. UCHealth invests in its Workforce. UCHealth offers a Three Year Incentive Bonus to recognize employee's contributions to our success in quality, patient experience, organizational growth, financial goals, and tenure with UCHealth. The bonus accumulates annually each October and is paid out in October following completion of three years' employment. UCHealth offers their employees a competitive and comprehensive total rewards package (benefit eligibility is based off of FTE status): + Medical, dental and vision coverage including coverage for eligible dependents + 403(b) with employer matching contributions + Time away from work: paid time off (PTO), paid family and medical leave (inclusive of Colorado FAMLI), leaves of absence; start your employment at UCHealth with PTO in your bank + Employer-paid basic life and accidental death and dismemberment coverage with buy-up coverage options + Employer paid short term disability and long-term disability with buy-up coverage options + Wellness benefits + Full suite of voluntary benefits such as flexible spending accounts for health care and dependent care, health savings accounts (available with HD/HSA medical plan only), identity theft protection, pet insurance, and employee discount programs + Education benefits for employees, including the opportunity to be eligible for 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. Other programs may qualify for up to $5,250 pre-paid by UCHealth or in the form of tuition reimbursement each calendar year Loan Repayment: + UCHealth is a qualifying employer for the federal Public Service Loan Forgiveness (PSLF) program! UCHealth provides employees with free assistance navigating the PSLF program to submit their federal student loans for forgiveness through Savi. UCHealth always welcomes talent. This position will be open for a minimum of three days and until a top applicant is identified. UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individual's race, color, national origin, language, culture, ethnicity, age, religion, sex, disability, sexual orientation, gender, veteran status, socioeconomic status, or any other characteristic prohibited by federal, state, or local law. UCHealth does not discriminate against any qualified applicant with a disability as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization. Who We Are (uchealth.org)

National Jewish Health is seeking a Clinical Research Coordinator (CRC) to join our team of lung disease researchers within the Division of Environmental and Occupational Health Sciences (DEOHS). The candidate selected for this role will be detail-oriented, coachable, and highly motivated. We are particularly eager to find someone who has experience interacting directly with patients. The role of a CRC on our team varies some from day to day and all team members are cross trained to contribute to all of our clinical programs. This coordinator will primarily work with our Sarcoidosis and Interstitial Lung Disease research programs. Major job duties include recruiting participants in our clinics for research, conducting interviews, reviewing medical records, entering study data, and helping meet study regulatory and funding requirements. Our team invests in training our CRCs so that they become highly skilled at multiple tasks. The ideal candidate will have the ability to work both independently and as an integral member of a team. Phlebotomy experience along with analytical skills and familiarity with database and statistical software are a plus. As the leading respiratory hospital in the nation, National Jewish Health is pioneering a new era of preventive and personalized medicine. By combining our efforts in comprehensive care, academic education and ground-breaking research, we're able to develop approaches to care and treatment that help our patients live more productive lives. Position Summary The Clinical Research Coordinator position is a study coordinator with proven ability to work independently. Acts as a preceptor for Assistant Clinical Research Coordinator and Clinical Research Coordinator. Essential Duties Consistently applies Clinical Research Guidelines including Good Clinical Practice, HIPAA regulations, CRS Standard Operating Procedures, applicable NJH Policies and Procedures, and FDA, NIH, OHRP, ICH guidelines as applicable. Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies. Independently performs study-related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies and NJH competency requirements. Complies with regulatory bodies to create and maintain study records, and if applicable, dispensation and accountability of investigational product. Efficiently implements and successfully executes complex research studies with high quality and appropriate enrollment. Provides general guidance to new staff and study coordinators. 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. Attention to Detail: Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed. Champion of Change: Facilitating the implementation and acceptance of change within the workplace. Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others. Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others. Patient Relations: Meeting patient and patient family needs; taking responsibility for a patient's safety, satisfaction, and clinical outcomes; using appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence. Drive for Results: Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement. Professional Development or Continuous Learning and Development: Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill to enhance their contribution to the organization. Initiative: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive. Supervisory or Managerial Responsibility None Travel Less than 10% Core Values Be available to work as scheduled and report to work on time. Be willing to accept supervision and work well with others. Be well groomed, appropriately for your role and wear ID Badge visibly. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually. Promotes a workplace culture based on mutual respect and merit, where all individuals are treated fairly and provided with equal opportunity to contribute to the mission and goals of the institution. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures. Wears appropriate PPE as outlined by the infection control policies and procedures. Demonstrates compliance with all state, federal and all other regulatory agency requirements. Minimum Qualifications Education: Bachelor's degree required. Work Experience: A minimum of 1 year clinical research experience required. Special Training, Certification or Licensure: BLS required within one month of hire. CITI training required within one month of hire. Salary Range: $25.04 - $33.11 Benefits At National Jewish Health, we recognize that our outstanding faculty and staff are the essence of our organization. For every aspect of health care, our employees are our greatest asset. With that in mind, we have designed a valuable, comprehensive benefits package to meet the needs of our employees and their families. Comprehensive Medical Coverage: Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans. Paid Time Off: Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations. Dental & Vision Plans: Coverage effective the first of the month after hire. Retirement Savings: 403(b) plan with employer contributions after two years. Wellness Incentives: Earn up to $200 annually for preventive health activities. Tuition Reimbursement: Up to $5,250 annually for full-time and part-time employees. Child Care Assistance: Childcare Flex Spending Account (FSA) with annual employer contribution. Loan Forgiveness: Public Service Loan Forgiveness (PSLF) eligible employer. Disability & Life Insurance: Employer-paid plans and optional buy-up choices. Voluntary Benefits: Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan Exclusive Discounts: Savings on local services, insurance, and RTD bus passes. Anticipated Application Deadline: 2026-01-16

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#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.

Why Join Us? At United Urology Group, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care. We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff! We deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies. We offer competitive salaries and a great work/life balance: enjoy your weekends! UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more! : The Research Coordinator will screen, enroll, and follow study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are on study. Primary Duties & Responsibilities: Conducting Clinical Trials Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation. Review the protocol and the informed consent form for accuracy and clarity. Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff. Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP). Schedule site Sponsor visits in accordance with internal SOP. Prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory Specialist, when applicable. Ensure maintenance and calibration of site study required equipment. Enrollment of Study Subjects Review the study design and inclusion/exclusion criteria with the PI/SI, and if needed the Sponsor to ensure understanding. Review, verify, and record/collect all relevant documentation in the subject's medical record needed to confirm study eligibility. Review the protocol, informed consent form, and follow-up procedures with the potential study subjects. Ensure the current approved informed consent is signed before subjects are screened and enrolled. Inform and document notification of the subject's Primary Care Physician of trial participation if approved by the subject. Perform delegated Protocol specific tasks as assigned by Principal Investigator. Ensure that the randomization procedures are followed and documented per protocol guidelines. Document protocol exemptions and deviations, as appropriate. Ensure duplication of each for filing in the subject source and with the regulatory specialist. Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOP. Follow-Up Procedures Schedule subjects for follow-up visits, collect subjects' responses to therapy, and interview subjects for adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during the subject visit for any notable medical/medication changes from the last research visit. Review laboratory data and communicate abnormal values to the PI/SI and as needed, primary care provider or specialist if additional medical attention is needed. Assess and document subject compliance and accountability with Investigational Product (IP). Document re-education when appropriate. Communicate with research staff to ensure timely and accurate study drug distribution when applicable. Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved. Record all Adverse Events outlined in protocol and review them with the PI/SI. Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject's primary care physician or specialist. Administrative/Clerical Reporting all Deviations/Adverse/SAE within Sponsor/IRB's timeframe and in accordance with site SOP. Follow SOPs/GCPs/HIPPA according to the site, sponsor, ICH, and FDA. Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications. Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight, and that the site Regulatory Specialist receives reviewed/corrected/signed copy of the report. File appropriate regulatory or Sponsor communications with the site Regulatory Specialist. Create and maintain Master Subject Log and Visit Log. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice. Qualifications: Minimum High School Diploma or GED required. Minimum of two (2) years of clinical research experience. Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI) required and will be verified prior to employment. Knowledge, Competencies & Skills: Exceptional customer service skills. Strong attention to detail, a willingness to learn & the ability to stay organized. Ability to perform clinical assessments. Strong understanding of FDA clinical trial phases I-IV. Strong understanding of GCP set forth by the ICH. Proficient knowledge of medical terminology. Proficient knowledge of Research-related Terminology. Strong communication skills, both verbal & written. Proficient computer software and database skills. Comfortable working in a fast-paced environment. Very comfortable asking probing questions to patients, if applicable. Must demonstrate a caring, compassionate, and patient attitude. Maintain HIPAA compliance. Multitasking and proactive problem-solving. Ability to type a minimum of 40 words per minute. Job Type: Full-Time Pay Range: $30.00 - $31.50 per hour Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws. This position has no close date. Applications will be accepted until an offer has been extended and accepted. Equal Opportunity Employer: Our Practice is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation. The successful candidate(s) for any UUG position will be subject to a pre-employment background check.

Medpace is delighted to host a Virtual Recruitment Event tailored to candidates studying or holding a PhD in Life Science areas, working within Cardiovascular, Nephrology / Renal or Gastrointestinal (GI) research areas. This is an exciting opportunity for individuals seeking to make a switch from academia to the Clinical Trials Industry! LOCATION: Virtual - Microsoft Teams Link will be shared with candidates selected to attend. DATE: January 29, 2026 at 5:30 pm eastern time. Please include your resume and attach a cover letter with your application. Associate Clinical Trial Manager At this event, Medpace is seeking to meet candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial Manager (aCTM) role to join our global Clinical Operations team. The aCTM will be working closely with Project Coordinators and Clinical Trial Managers in performance of clinical trial management activities. Candidate must have a desire to transfer and apply analytical and academic skills in clinical project administration and management. This is a fantastic opportunity for recent PhD graduates to enter the industry, receive solid foundational training, work in an international environment, and accelerate their career in the research and development of cutting-edge therapeutics. Candidates should expect to have an intensive training period and show the desire and aptitude for an accelerated career path into Clinical Trial Management (CTM). What to Expect Next: A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an RSVP. Responsibilities * Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager * Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy * Compile and maintain project-specific status reports within the clinical trial management system * Interact with the internal project team, Sponsor, study sites, and third-party vendors * Provide oversight and quality control of our internal regulatory filing system * Provide oversight and management of study supplies * Create and maintain project timelines * Coordinate project meetings and produce quality minutes Qualifications * PhD in Life Sciences area is required; upcoming PhD graduates or Postdocs are welcome to apply! * A background in one of our key therapeutic focus areas: Cardiovascular, Renal / Nephrology, GI/Gastrointestinal/Gastroenterology; * Fluency in English with solid presentation skills; and * Ability to work in a fast-paced dynamic industry Medpace Overview Medpace is a full-service clinical contract research organisation (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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.

Department: MCR MCR Research (Trauma/Critical Care/Multidisciplinary) FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $24.11 - $36.17 / hour. Pay is dependent on applicant's relevant experience Summary: Coordinates the administrative and clinical aspects of research projects. Responsibilities: * Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols. Monitors and reports on progress of projects as necessary. * Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Performs specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. * Coordinates with investigator to manage adverse events, compliance and other participant-related issues. Facilitates the education of necessary parties such as participants, sponsors and clinicians involved in service delivery. * Implements and oversees the study's compliance with applicable regulations and standards. Assists with responding to and preparing for audits. * Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action. Requirements: * Bachelor's degree. * 2 years of experience coordinating clinical research studies and clinical trials, or 2 years of experience in data management and knowledge of IRB clinical research application procedures. * BLS through the American Heart Association or the American Red Cross CPR for the Professional Rescuer with card in-hand before start date. BLS or CPR card must be good through sixty days of hire. Preferred: * Comfortable in the ER, Inpatient settings and with seeing full traumas * Experience with data studies We improve lives. In big ways through learning, healing, and discovery. In small, personal ways through human connection. But in all ways, we improve lives. UCHealth invests in its Workforce. UCHealth offers a Three Year Incentive Bonus to recognize employee's contributions to our success in quality, patient experience, organizational growth, financial goals, and tenure with UCHealth. The bonus accumulates annually each October and is paid out in October following completion of three years' employment. UCHealth offers their employees a competitive and comprehensive total rewards package (benefit eligibility is based off of FTE status): * Medical, dental and vision coverage including coverage for eligible dependents * 403(b) with employer matching contributions * Time away from work: paid time off (PTO), paid family and medical leave (inclusive of Colorado FAMLI), leaves of absence; start your employment at UCHealth with PTO in your bank * Employer-paid basic life and accidental death and dismemberment coverage with buy-up coverage options * Employer paid short term disability and long-term disability with buy-up coverage options * Wellness benefits * Full suite of voluntary benefits such as flexible spending accounts for health care and dependent care, health savings accounts (available with HD/HSA medical plan only), identity theft protection, pet insurance, and employee discount programs * Education benefits for employees, including the opportunity to be eligible for 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. Other programs may qualify for up to $5,250 pre-paid by UCHealth or in the form of tuition reimbursement each calendar year Loan Repayment: * UCHealth is a qualifying employer for the federal Public Service Loan Forgiveness (PSLF) program! UCHealth provides employees with free assistance navigating the PSLF program to submit their federal student loans for forgiveness through Savi. UCHealth always welcomes talent. This position will be open for a minimum of three days and until a top applicant is identified. UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individual's race, color, national origin, language, culture, ethnicity, age, religion, sex, disability, sexual orientation, gender, veteran status, socioeconomic status, or any other characteristic prohibited by federal, state, or local law. UCHealth does not discriminate against any qualified applicant with a disability as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization. Who We Are (uchealth.org)

Posting Title Senior Electric Grid Cybersecurity Researcher . . Type Regular . Hours Per Week 40 . Working at NLR NLR 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 Qualifications Relevant 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 Summary Benefits 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 Requirement NLR 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.

Clinical Research Coordinator - Centennial, CO Compensation: $50,000 - $70,000 Annually Overview: Nexus HR is seeking a Clinical Research Coordinator to join our team. In this pivotal role, you will maintain a neat and professional appearance, demonstrate commitment to serve at all times, uphold guidelines as set forth in the employee handbook, and maintain patient confidentiality at all times. About the Job The Clinical Research Coordinator is involved in all aspects of clinical trials research from pre-study planning to study completion, and includes direct involvement in case management of study participants. Works under the supervision of the Principal Investigator and Site Manager. Duties and Responsibilities: Own end-to-end management and execution of all clinical research activities Independently conduct and complete study visits, including protocol review with the Principal Investigator Lead patient recruitment and retention initiatives and support internal study marketing efforts Ensure compliant informed consent before any study procedures Review medical records and eligibility criteria with investigators or site leadership Perform safety assessments (e.g., vitals, venipuncture, ECGs) Create, maintain, and complete source documentation and regulatory binders Schedule subjects, manage follow-up, and coordinate with physicians and sponsors Collaborate with clinical teams to ensure protocol adherence and documentation accuracy Complete CRFs and manage queries in a timely, compliant manner. Coordinate research operations across multiple studies, phases, and therapeutic areas Complete and maintain training in ICH/GCP, HIPAA, SOPs, IATA, and other required technical skills Understand Investigator and Site responsibilities under FDA, DHHS, and OHRP regulations Knowledgeable of the drug development process (IND to NDA, IDE to PMA, Phases I-IV) Comprehend and communicate informed consent elements per the Declaration of Helsinki Understand IRB regulations and their role in clinical trials Identify and report adverse and serious adverse events promptly Participate in site initiation, monitoring, and closeout visits, as well as sponsor meetings Engage in peer review of data quality Adhere to company policies and procedures Maintain regular attendance as an essential job function Qualifications: Bachelor's degree in biology, chemistry, human sciences, or a related scientific field; relevant clinical experience may substitute 2-5 years of healthcare and/or clinical research experience. Certification in the field (CCRC, CCRA, or CCRP) preferred Strong attention to detail and organizational skills Excellent written and verbal communication Ability to manage multiple studies concurrently Proficient in basic computer applications Demonstrates honesty, integrity, and professionalism Effective team player in a high-performance environment Benefits: 401(k) and 401(k) matching Health, dental, and vision insurance Life and disability insurance (short-term and long-term) Flexible spending accounts (FSA) Health Savings Accounts (HSA) Employee Assistance Program (EAP) Paid time off (PTO) and holiday pay Wellness programs

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

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. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. 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_