Description
Job Responsibilities- Daily activities will vary depending on the clinical phase of the program. Will have responsibilities for managing more than one project. Determine methods and procedures for performing new assignments. Oversee the activities of CTAs and CRAs.
- Manage contract research organization (CRO) personnel and study sites to ensure studies are completed on time, within budget and in compliance with the protocol, GCPs, FDA regulations and ICH/GCP guidelines, and overall clinical objectives.
- Manage all study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
- Supervise monitoring activities of study data verification on source documentation and case report forms (CRFs) to ensure compliance with the study protocols, GCPs, and SOPs. Ensure data discrepancies are identified and resolved.
- Supervise on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Review site visit reports.
- Supervise activities related to the preparation of all study-related clinical documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
- Participate in the evaluation and selection of sites and CROs, and planning of clinical meetings (investigator meeting, steering committee meeting, CRO kick-off meetings, etc.)
- Broad knowledge of FDA and ICH regulatory requirements.
- Assist in the preparation of study protocols, IBs, and regulatory submissions.
- May represent clinical operations in project team meetings.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- BS, RN/PA, BSN degree or equivalent, with 8+ years of clinical research experience, of which at least 5 years must be industry in-house experience.
- Experience in one or more of the following therapeutic areas: inflammation, infectious disease, and/or oncology.
- Demonstrated management experience of regional and in-house CRAs a plus
- Broad knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials.
- Proven ability to exercise independent judgment, use critical-thinking to analyze problems which may require multiple factors and approaches.
- Excellent technical writing skills.
- Proven experience working in cross functional project teams.
- Computer proficiency.
- The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment and needs to occasionally move about the office for meetings, to access files, and other office equipment.
- Must be able to travel up to 25%.
- BS, RN/PA, BSN degree or equivalent, with 8+ years of clinical research experience, of which at least 5 years must be industry in-house experience.
- Experience in one or more of the following therapeutic areas: inflammation, infectious disease, and/or oncology.
- Demonstrated management experience of regional and in-house CRAs a plus
- Broad knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials.
- Proven ability to exercise independent judgment, use critical-thinking to analyze problems which may require multiple factors and approaches.
- Excellent technical writing skills.
- Proven experience working in cross functional project teams.