What are the responsibilities and job description for the Clinical Research Manager, Medicine (Cardiology) position at Medical Faculty Associates, Inc.?
This leadership role oversees the clinical research staff assigned to the Department of Cardiology. The Clinical Research Manager ensures compliance with federal regulations, GW University policies, and Good Clinical Practice (GCP) guidelines. This position plays a vital role in aligning research operations with strategic goals, enhancing research integrity, and improving patient-focused outcomes through effective trial execution. The manager will also be expected to participate in and support research projects as part of the clinical research team.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
- Supervise and support clinical research coordinators and staff within Cardiology, providing study-specific training and oversight.
- Collaborate with Principal Investigators (PIs) and sponsors to define clinical trial recruitment targets and timelines.
- Assist in the development and submission of IRB protocols and FDA IND applications.
- Develop study-specific monitoring tools and ensure proper documentation practices.
- Create, manage, and monitor clinical trial budgets in collaboration with the Clinical Research Finance team.
- Coordinate sponsor site visits and manage trial documentation to ensure accuracy and regulatory compliance.
- Support the preparation and review of informed consent forms, ensuring clear and accurate language in line with study guidelines.
- Ensure compliance with institutional SOPs, federal regulations (CFR), and ICH-GCP standards.
- Learn to assist faculty with grant proposals and identify funding opportunities.
- Participate in monthly invoicing for funded trials and support financial tracking, including outstanding payments and accounts receivable with the post-grant team and Drs Gomberg and Panjrath.
- Help resolve research-related billing issues in collaboration with GW MFA and Hospital billing teams.
- Manage onboarding and orientation of new clinical research staff with the Office of Clinical Research.
- Take on special projects as needed by the cardiology research leads and or the Directors of the Office of Clinical Research.
Minimum Qualifications
Education
- A Bachelor's degree or higher in a related discipline
Experience
- A minimum of six years of clinical research experience
Physical Requirements
- Walk, bend, twist, and reach above the shoulder frequently in an office setting.
- Must be able to occasionally lift or carry and frequently push or pull up to 20 lbs. as part of the role
- Regularly exposed to healthcare settings that may require personal protective equipment
- Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment
About GW MFA
MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers, preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals.
The GW MFA’s leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.