Clinical Research Manager Jobs

Title: Clinical Research Manager

Center: Center for Behavioral Oncology

Department: Population Health Science and Policy

Work Week: M-F, hybrid

Benefits: Yes

PT/FT: FT

A full-time Clinical Research Manager (CRM) is sought for an NCI-funded randomized clinical trial (PI, Dr. Guy Montgomery) investigating the effects of an information-sharing intervention to encourage mammography patients with markers of coronary artery disease to seek cardiovascular care. The CRM will provide regulatory, data management, administrative, and other research support to the project, will directly supervise a team of 3 research coordinators, and will be part of a team including clinical psychologists, breast radiologists, and cardiologists. Successful candidates will have a high degree of professional maturity, empathy, commitment to excellence, attention to detail, independence, flexibility, and creativity.

Key Responsibilities include but are not limited to:

Research:

• Develop appropriate progress reports for the PI, study funding agency, and the IRB.
• Prepare for monitoring and/or audits, as needed, and respond to any findings to implement recommended action items.
• Develop and manage the research program and execution of research studies in consultation with principal investigators to meet changing needs and requirements of the sponsor and studies.
• Lead quarterly Data and Safety Monitoring Board (DSMB) meetings and prepare quarterly reports providing information on study enrollment, study progress, adverse events, protocol deviations, and overall patient and study safety.
• Supervise study research coordinators, including monitoring recruitment, data entry, tracking patient participation throughout the study lifecycle, and conducting weekly meetings.
• Prepare Institutional Review Board (IRB) study submissions, continuing reviews, amendments, and adverse event reporting.
• Monitor efforts related to human research participant protection and report instances of noncompliance to the appropriate compliance office.
• Screen subjects for eligibility using specific inclusion and exclusion criteria.
• Manage day-to-day clinical research operations including study execution, monitoring, and safety compliance, developing policies and procedures, maintaining all study documents (e.g., electronic regulatory binder and consent forms), and ensuring adherence to HIPAA (Protection of Human Research Subjects) standards, Good Clinical Practice (GCP), and guidelines established by the Institutional Review Board (IRB) and the National Cancer Institute.

Minimum Education:

Master’s degree

Minimum Related Experience:

• Ability to effectively interact with multidisciplinary teams including physicians and administrative staff.
• Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.
• Previous experience supervising staff.
• Excellent communication, writing, organizational and presentation skills.
• 2-3 years of experience coordinating or managing clinical trials.
• Previous experience with participant recruitment.
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA).

Minimum Computer Skills:

Advanced MS Office (Word, Excel), Outlook

Preferred Qualifications:

• Previous experience conducting monitoring visits with study sponsors.
• Master’s degree in related scientific area (e.g., psychology, public health, other science).
• Certification as a clinical research professional (SOCRA) or clinical research coordinator (ACRP).
• Using data capturing software (e.g., REDCap).