Clinical Research Manager

Vivent Health • Denver, CO

5d

About The Position

The Clinical Research Manager is responsible for the operational management, regulatory compliance, quality, and performance of Vivent Health’s clinical research program. The role oversees research studies, research personnel, and the systems and processes required for high-quality, compliant, and efficient research operations. The manager collaborates with Principal Investigators, healthcare providers, clinical and operational leaders, sponsors, CROs, and other stakeholders to assess research opportunities, prepare the organization for studies, support study execution, and integrate research into clinical operations. The position also supports the program’s financial sustainability and continued development.

The manager leads day-to-day program operations, supervises and develops staff, oversees the study portfolio from feasibility through close-out, and maintains policies, SOPs, and workflows. The role ensures compliance with GCP, IRB requirements, protocols, sponsor requirements, and applicable regulations; safeguards participants; oversees quality and data integrity; and maintains inspection readiness. It also supports equitable participant recruitment and retention, research systems and metrics, coordination with clinical teams, sponsor relationships, budgets and financial compliance, and implementation of the program’s research strategy. Travel to other locations may be required.

Vivent Health describes its mission as ending HIV/AIDS through integrated, personalized, judgment-free care and emphasizes equity, dignity, access, collaboration, and inclusive engagement. The organization is an equal opportunity employer and is committed to a diverse, supportive, and inclusive environment.

Requirements

• Bachelor’s degree in health sciences, life sciences, public health, healthcare administration, business administration, nursing, research, or a related discipline.
• At least 5 years of progressively responsible clinical research experience, including clinical research operations and work in an environment dealing with research and funding.
• At least 2 years of experience leading and developing people and fostering a collaborative, mission-driven team environment.
• Demonstrated experience supervising or managing clinical research personnel.
• Experience working with sponsors and/or CROs.
• Experience with clinical research study start-up and feasibility assessment.
• Current GCP and human subjects protection training, such as CITI, with renewal as required by the IRB and sponsors.
• Proficiency with MS Office, Windows, and databases.
• Experience with the IRB approval process and research study protocols.
• Strong knowledge of GCP, IRB requirements, informed consent, clinical trial operations, research documentation, and regulatory compliance.
• Demonstrated leadership, communication, project-management, and problem-solving skills.
• Ability to build effective working relationships with investigators, clinicians, sponsors, and community partners, and to escalate issues appropriately.
• Commitment to participant protection, confidentiality, and respectful, inclusive engagement with people affected by HIV.

Nice To Haves

• Master’s degree.
• Clinical research certification such as ACRP-CP, CCRC, CCRP, or equivalent; in-progress status is acceptable.
• Phlebotomy certification; in-progress status is acceptable.
• Experience with clinical trial management, electronic data capture, or electronic regulatory systems.
• HIV experience in a not-for-profit environment.
• Experience managing industry-sponsored clinical trials.
• Experience with clinical research budgets, contracts, and financial management.
• Experience establishing or expanding a clinical research program.
• Experience conducting research within community health, nonprofit healthcare, infectious diseases, or populations historically underrepresented in clinical research.

Responsibilities

• Lead day-to-day clinical research program operations, including staffing, workload, and resource allocation.
• Supervise, coach, and develop research staff; set performance expectations and ensure training, competencies, and credentials remain current.
• Oversee the study portfolio from feasibility and start-up through conduct and close-out, including operational feasibility, activation readiness, and records retention.
• Develop and maintain research policies, SOPs, and workflows.
• Ensure research complies with GCP, including ICH E6(R3), IRB requirements, approved protocols, sponsor requirements, and applicable regulations.
• Oversee informed consent, participant privacy including HIPAA, and timely adverse-event reporting.
• Oversee quality management, data integrity, and inspection readiness, including preparation for sponsor, CRO, and regulatory monitoring visits and audits.
• Review protocol deviations and compliance issues, lead corrective and preventive action plans, and escalate significant compliance or participant-safety concerns to appropriate leaders.
• Oversee participant recruitment and retention, address barriers, and promote equitable access for populations historically underrepresented in clinical research.
• Oversee research data collection and management systems, such as CTMS, EDC, and eRegulatory systems, and report program metrics to the Clinical Research or Medical Director.
• Partner with Principal Investigators, Medical Directors, providers, Pharmacy, and laboratory teams to integrate research into clinical care and oversee investigational product accountability.
• Serve as primary operational liaison with sponsors, CROs, and research partners; escalate significant sponsor, contractual, financial, or strategic matters to the Clinical Research Director.
• Participate in study budget development and review, monitor financial performance and research billing compliance, and work with Finance, Legal, and Compliance on Clinical Trial Agreements, invoicing, and participant payments.
• Support the Clinical Research Director in implementing research strategy and developing a sustainable, high-quality program.
• Travel to other locations as needed.
• Adhere to agency policies, including confidentiality, the Employee Handbook, the Health Care Corporate Compliance Plan, Standards of Conduct, and applicable training and policies.
• Perform additional job-related tasks as needed.

Benefits

• Generous PTO, including 12 paid holidays.
• 401(k) with 100% employer match up to 5%.
• 12 weeks of fully paid parental leave for benefits-eligible employees after one year.
• Employer-subsidized medical, dental, vision, and gender-affirming care.
• Tuition reimbursement and licensure assistance.
• Public Student Loan Forgiveness eligibility for qualifying employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager