Clinical Research Manager - Cardiovascular and Cardiothoracic Research
University of Kansas Medical Center
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Benefits offered by this job
Job summary
The University of Kansas Medical Center invites applications for a Clinical Research Manager in the Cardiovascular and Cardiothoracic Research program. This role plans, coordinates, and oversees operational aspects of clinical studies, including timelines, budgets, contracts, submissions, and study deliverables.
You will collaborate with investigators, sponsors, CROs, and external sites to ensure compliant study execution, establish SOPs, monitor quality, and drive efficient research operations
Qualifications
- Certification/Licenses: Research certification such as CCRC, CCRP, ACRP is required.
- Ten (10) years of work experience in healthcare or research settings.
- Experience with CFR, GCP, HIPAA regulations and regulatory affairs in clinical research.
Responsibilities
- Plan, coordinate and oversee all phases of clinical research studies including industry-sponsored, federally funded, investigator-initiated, and multi-site trials.
- Develop and manage study timelines, deliverables, budgets, contracts, and agreements to ensure projects are completed on time and within budget.
- Coordinate study start-up activities including regulatory submissions, contract execution, IRB approvals, ancillary approvals, credentialing, and site activation.
- Monitor project progress, identify risks, resolve operational issues, and implement solutions to support successful study execution.
- Collaborate with principal investigators, study teams, sponsors, CROs, external study sites, and institutional partners throughout the study lifecycle.
Skills
Education
Job description
The Clinical Research Manager oversees clinical research activities led by investigators and faculty within the assigned research program. This role plans, coordinates, and executes operational aspects of clinical research, including managing project timelines, budgets, contracts, agreements, and study deliverables. The Clinical Research Manager collaborates with principal investigators, research teams, and institutional partners to support successful study execution, develop and implement standard operating procedures, oversee administrative support functions, and improve research operations.
- Plan, coordinate and oversee all phases of clinical research studies including industry-sponsored, federally funded, investigator-initiated, and multi-site trials.
- Develop and manage study timelines, deliverables, budgets, contracts, and agreements to ensure projects are completed on time and within budget.
- Coordinate study start-up activities including regulatory submissions, contract execution, IRB approvals, ancillary approvals, credentialing, and site activation.
- Monitor project progress, identify risks, resolve operational issues, and implement solutions to support successful study execution.
- Collaborate with principal investigators, study teams, sponsors, contract research organizations (CROs), external study sites, and institutional partners throughout the study lifecycle.
- Develop, implement, and maintain standard operating procedures (SOPs), study manuals, source documents, case report forms, and other study documentation as appropriate.
- Assist with the development, review, and submission of research protocols, informed consent documents, and regulatory materials.
- Establish and oversee quality management activities, including monitoring study performance, recruitment, retention, data quality, protocol compliance, and corrective and preventive action (CAPA) plans.
- Track protocol deviations and support corrective actions to ensure compliance with institutional, sponsor, and regulatory requirements.
- Participate in internal and external audits, inspections, and quality improvement initiatives.
- Assist with study feasibility assessments, budget development and review, and financial oversight of assigned projects.
- Track project milestones and prepare operational and research progress reports for investigators, sponsors, and funding agencies.
- Support implementation and ongoing management of research systems and operational processes.
- Supervise and provide direction to assigned research and administrative staff including hiring, onboarding, orientation, training, and performance management as applicable.
- Provide mentorship, coaching, and operational guidance to study teams to promote collaboration, consistency, and efficient study execution.
- Coordinate staff assignments and cross-coverage to meet project and operational needs.
- Serve as the primary operational liaison among investigators, study teams, sponsors, CROs, research sites, laboratories, pharmacies, and institutional departments.
- Foster effective communication across internal and external stakeholders to support timely study activation, enrollment, and completion.
- Provide consultation and operational support to study teams to address project challenges and improve research processes.
- Perform clinical research duties, as needed, to support study operations at any level from Clinical Research Assistant through Clinical Research Supervisor, including participant assessments, informed consent, specimen processing, and protocol-required study procedures.
- Certification/Licenses: Research certification required such as Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Association of Clinical Research Professionals (ACRP).
- Ten (10) years of work experience in healthcare or research setting.
- Work experience with regulations governing clinical research (CFR, GCP, HIPAA) and statutes and guidelines relevant to regulatory affairs in clinical research.
- Education: Master’s degree in a health-related field.
- Six (6) years’ experience managing or coordinating clinical trials in an academic medical center.
- Organization
- Detail-Oriented
- Multitasking
- Communication
- Time management
- Prioritization
- Delegation
Resume Cover Letter
- Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
- Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
- Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
- One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
- A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.
- https://www.kumc.edu/human-resources/benefits.html
- Employee Type: Regular
- Time Type: Full time
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range: $92,800.00 - $139,200.00 Minimum $92,800.00 Midpoint $116,000.00 Maximum $139,200.00
The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care.
The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.
Under Kansas state law, certain KUMC positions are subject to disability preference. For positions subject to this requirement, KUMC will offer an interview to a person who has applied for an open position who is qualified, with or without reasonable accommodation, to meet the performance standards of the position and who has presented acceptable proof of disability. If the position you apply for is subject to the disability preference requirement, you will be asked to provide information in support of your request for disability preference when you complete the application for employment.
- https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf
- https://www.laborposters.org/federal/1606-federal-pay-transparency-poster.htm
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