Specialist, Site Manager - Oncology
- United States
Janssen Research & Development, LLC, a member ofJohnson & Johnson's Family of Companies, is recruiting for a Specialist, Site Manager - Oncology. This position can be located remotely within the United States.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Specialist, Site Manager (Specialist, SM) will overseeTrial Coordination and Site Management and 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.
- Provide strong leadership, process initiative, influencing and mentoring skills.
- May assume additional responsibilities or special initiatives such as Champion or Therapeutic Area Expert.
- Participate in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
- Act as primary local company contact for assigned sites for specific trials.
- 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.
- Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arrange for the appropriate destruction of clinical supplies.
- Ensure site staff complete data entry and resolve queries within expected timelines.
- Ensure accuracy, validity and completeness of data collected at trial sites
- Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Fully document trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Collaborate with LTM for documenting and communicating site/study progress and issues to trial central team.
- Attend regularly scheduled team meetings and trainings.
- Comply with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Work closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- Prepare trial sites for close out, conduct final close out visit.
- Track costs at site level and ensure payments are made, if applicable.
- Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and Independent Ethics Committee (IEC) /Institutional Review Board (IRB) submission and notification processes as required/appropriate.
- Act as a point of contact in site management practices.
- May be assigned as a coach and mentor to a less experienced SM.
- May contribute to process improvement and training.
- Lead and/or participate in special initiatives as assigned.
- A minimum of an Associate's degree or completion of a Nursing Program (RN) is required. A Bachelor's degree in a Health or Science discipline is preferred.
- A minimum of 4 years of clinical trial monitoring experience is required.
- Clinical research monitoring experience in Oncology is required.
- Experience with CAR-T (Cell and Gene Therapy) is preferred.
- Experience with Phase II and Phase III Clinical Trials is 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.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
Janssen Research & Development, LLC (6084)
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