Associate Site Manager, Clinical Trial Support

Johnson & Johnson Innovative Medicine•Raritan, TX

3d•Remote

About The Position

The Associate Site Manager (Associate SM) will serve as the primary contact point between the Sponsor and the Investigational Site. The Associate SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. This individual may assist with site selection, site qualification 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 TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior Site Manager (Senior SM or Lead SM) to help provide guidance.

Requirements

A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
A minimum of 1 year of clinical trial monitoring experience is required.
Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, 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 up to 60% with overnight stay away from home is required.
A valid Driver's License issued in one of the 50 United States and a good driving record is required.

Nice To Haves

Experience with Phase II and Phase III Clinical Trials is preferred.

Responsibilities

Act as primary local company contact for assigned sites for specific trials.
Actively participate in site feasibility and/or Site Qualification Visits (SQVs).
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.
Implementation of analytical risk-based monitoring model at the site level and work with the 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 point during all trial phases.
Collaborate closely 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 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 that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
Fully document trial related activities, in particular monitoring.
Write visit reports and follow-up letters in accordance with the SOPs.
Promptly communicate relevant status information and issues to appropriate stakeholders.
Review study files for completeness and ensure 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.
Active participation in regularly scheduled team meetings and trainings.
Provide feedback as appropriate.
May be asked to lead/provide leadership at these meetings.
Comply with relevant training requirements.
Act as local expert in assigned protocols.
Develop therapeutic knowledge sufficient to support role and responsibilities.
Works 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. Compliance Monitoring Visit (CMV).
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, in particular 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 contribute to process improvement and training.