This position will assist in the planning and implementation of post-marketing clinical studies including, but not limited to, coordination of medical affairs related study activities to ensure compliance with the protocol, Good Clinical Practice (GCP), government regulations, and overall medical affairs objectives.
Daily activities will vary depending on the objectives of each post-marketing study. Receive minimal to no instructions on routine work, and general instructions on new assignments.
Interact with contract research organization (CRO) personnel, investigators, and study sites to ensure studies are performed in compliance with the protocol, GCPs, government regulations, and overall study objectives.
Coordinate key study parameters including, but not limited to, study start-up activities, supplies preparation, enrollment, data collection, and close-out.
Verify study data on source documentation and case report forms (CRFs) to ensure compliance with the study protocol, GCPs, and Standard Operating Procedures (SOPs). Identify and resolve data discrepancies.
Conduct on-site monitoring visits as needed, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Prepare and review site visit reports.
Assist in generating study documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
Organize study meetings (investigator meeting, scientific advisory committee, steering committee meeting, CRO kick-off meetings, vendor calls, etc.).
Assist in the management of the investigator sponsored research (ISR) program for post-marketing studies.
Intermediate knowledge of FDA and ICH regulatory requirements.
May assist in preparing study reports.
May participate in project team meetings.
Support the organization in maintaining a work environment that fosters learning, open communication, collaboration, integration, and teamwork.
Other duties as assigned.
BS, RN/PA, BSN degree or equivalent, and at least 3 years of industry clinical research experience. Half of this experience may be in-house and/or field experience gained through contract research organizations.
Experience in one or more of the following therapeutic areas: inflammatory disease and/or infectious disease. Vaccine and/or NDA or BLA filing experience a plus.
Good knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials.
Demonstrated ability in critical thinking, problem-solving, and sound judgment.
Excellent communication and interpersonal skills.
Personal attributes include:
Integrity and flexibility
Good organizational skills
Excellent attention to detail
Ability to prioritize and handle multiple tasks simultaneously
Practical approach to clinical and regulatory processes
Good judgment and decision-making experience
Action and goal-oriented
Collaborative and team-oriented
Must be able to travel up to 25%.