Website Johnson & Johnson
The Senior Site Manager (Senior SM) will serve as the primary contact point between the Sponsor and the Investigational Site. This individual will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other SMs.
- Act as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or pre-trial site assessment visits.
- Attend/participate in investigator meetings as needed.
- Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Implement of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Work in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contribute to site level recruitment and retention strategy and contingency planning and implementation in partnership with other functional areas.
Qualification & Experience:
- A minimum of an Associate’s degree or completion of a Nursing Program (LPN) is required. A Bachelor’s degree in Health, Science or Nursing (RN) is preferred.
- A minimum of 2 years of clinical trial monitoring experience is required.
- Clinical research monitoring experience in the Oncology Therapeutic Area is required.
- Experience with Oncology Solid Tumor clinical trials preferred.
- Experience with Late Development, Phase II and Phase III clinical trials preferred.
- Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Strong computer skills in appropriate software applications and related clinical systems required.
- Must have strong written and oral communication skills.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
Company: Sarasota, FL, US
Vacancy Type: Full Time
Job Location: Sarasota, FL, US
Application Deadline: N/A