Global Clinical Operations (GCO)
Position Title: Senior CRA - Senior Clinical Research Associate
A Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site.
A Senior Site Manager 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.
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. Site Manager will 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. A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.
1. Acts as primary local company contact for assigned sites for specific trials.
2. May participate in site feasibility and/or pre-trial site assessment visits
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing 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.
Responsible for the implementation 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.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible 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.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
7. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies.
10. Ensures site staff complete data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites.
12. Ensures 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.
13. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
14. Fully documents 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.
15. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
16. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
17. Attends regularly scheduled team meetings and trainings.
18. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
19. 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. On Site Quality Monitoring Visit (OSQMV).
20. Prepares trial sites for close out, conduct final close out visit.
21. Tracks costs at site level and ensure payments are made, if applicable.
22. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
23. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
24. Acts as a point of contact in site management practices.
25. May be assigned as a coach and mentor to a less experienced site manager.
26. May contribute to process improvement and training.
27. Leads and/or participates in special initiatives as assigned.
28. May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”.
Education and Experience Requirements
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
A minimum of 4 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Specific therapeutic area experience may be required depending on the position.
Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication.