Clinical Research Manager

Position Title:

Clinical Research Manager

Department:

Medicine

Job Type:

Full-Time

Position Summary

Department of Medicine - Division of Cardiovascular MedicineThe Department of Medicine, Division of Cardiovascular Medicine, is seeking a Project Administrative Officer to oversee the operational and administrative management of a high-volume clinical trials portfolio. This role is responsible for coordinating the day-to-day administration of cardiovascular and vascular clinical research studies and supervising research staff to ensure the successful execution of clinical trial protocols.

The Project Administrative Officer directs the day-to-day administration of clinical trials while ensuring studies are executed efficiently, ethically, and in full compliance with institutional, sponsor, and regulatory requirements. Working closely with principal investigators and departmental leadership, this position plays a critical role in advancing the divisions clinical research mission through effective program management, staff leadership, and operational excellence.

The Project Administrative Officer manages both pre-award and post-award activities, oversees study operations from start-up through close-out, and ensures compliance with institutional, sponsor, and regulatory requirements.

Key Responsibilities

Clinical Trial Operations

• Manage the day-to-day administrative and operational activities of cardiovascular and vascular clinical trials.
• Plan, develop, and oversee the execution of complex clinical research studies or study portfolios.
• Coordinate clinical trial logistics including site activities, subject recruitment, and study implementation.

Protocol Implementation & Oversight

• Participate in the planning, development, and implementation of clinical research protocols.
• Establish administrative, logistical, and operational procedures in accordance with study requirements and investigator guidance.
• Ensure all clinical activities are conducted in accordance with approved protocols, regulatory requirements, and institutional policies.
• Works closely with affiliate institutions to ensure protocol compliance in laboratory, imaging and clinical settings.

Staff Supervision

• Recruit, supervise, evaluate, and coordinate the activities of clinical research support staff.
• Provide guidance and oversight to ensure adherence to study procedures, clinical standards, and safety requirements.
• Manage time-off requests, payroll approval and submission of salaries via iLab.
• Foster a collaborative and high-performing research team environment.

Financial & Resource Management

• Assess operational, financial, and material requirements for clinical trials.
• Prepare and manage study budgets and coordinate procurement of clinical facilities, equipment, and supplies.

Regulatory & Compliance

• Ensure compliance with GCP, FDA, and applicable local regulatory requirements.
• Support regulatory submissions and inspections as needed.
• Manage relationships with study sponsors and investigators.
• Ensure compliance with data management standards and confidentiality of research subject information.
• Maintain oversight of regulatory documentation and ensure readiness for audits and sponsor reviews.
• Assist regulatory coordinator with training, documentation and study upkeep along with supporting initial submission.

Clinical & Study Coordination

• Monitor enrollment progress and key study metrics.
• Coordinate communication of study data and progress with investigators and study teams.
• Maintain complete source documentation and oversee preparation of required reports for sponsors and regulatory bodies.

Additional Responsibilities

• Maintain records related to investigational product dispensation and inventory management, when applicable.
• Contribute to the continued growth and success of the divisions clinical research program.
• Perform other related duties as assigned to support the clinical research mission of the division.

Minimum Qualifications

• Requires a bachelors degree in an appropriate field and at least five years of progressively more complex technical and managerial experience with related administrative experience to projects or programs involving external sponsors

Preferred Qualifications

• Advanced degree preferred
• Additional job-related knowledge gained by job experience or special study recommended.

Salary Range

$90,000 - $110,000