Clinical Research Manager
About the role
The 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.
Responsibilities
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.
Cook up clinical trial logistics including site activities, subject recruitment, and study implementation.
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.
Work closely with affiliate institutions to ensure protocol compliance in laboratory, imaging and clinical settings.
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.
Assess operational, financial, and material requirements for clinical trials.
Prepare and manage study budgets and coordinate procurement of clinical facilities, equipment, and supplies.
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.
Aid regulatory coordinator with training, documentation and study upkeep along with supporting initial submission.
Maintain records related to investigational product dispensation and inventory management, when applicable.
Contribute to the continued growth and success of the division’s clinical research program.
Qualifications
Requires a bachelor’s 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.
Advanced degree preferred.
Additional job-related knowledge gained by job experience or special study recommended.