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Sr Clinical Research Associate (Sr CRA)

Position Summary:

A Sr CRA is a mid-level site management role with typically 3-5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Sr CRA 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.

Principal Responsibilities:

1 Acts as primary local company contact for assigned sites for specific trials.

2 Actively May participate in site feasibility and/or Site Qualification Visit.

3 Attends/participates in investigator meetings as needed may be expected to help prepare meeting materials and may be required to present at the IM.

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.

5 Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.

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 Proactively 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.

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.

15 Reviews study files for completeness and ensures archiving retention requirements are met including storage in a secure area at all times.

16 Attends regularly scheduled team meetings and trainings.

17 Complies with relevant training requirements. Act as local expert in assigned protocols. Possesses proficient therapeutic knowledge sufficient to support role and responsibilities.

18 Prepares trial sites for close out conduct final close out visit.

19 Tracks costs at site level and ensure payments are made if applicable.

20 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. Able to provide credible and useful insights and input.

25 On need basis may be assigned as a coach and mentor to a less experienced CRA.

26 May be required to contribute to process improvement and training.

27 Occasionally leads and/or participates in special initiatives as assigned.

28 May be required to assume additional responsibilities or special initiatives such as Champion or Subject Matter Expert.

This is not an exhaustive comprehensive listing of job functions. May perform other duties as assigned.

Education and Experience Requirements:

A minimum of a BA or BS degree in Pharmacy Nursing Life Sciences or related scientific field (or equivalent experience) is required.

A minimum of 2 years of clinical trial monitoring experience is required. 3-5 years of clinical trial monitoring experience is preferred.

Specific therapeutic area experience may be required depending on the position and is an added advantage.

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.

Ability to work on multiple trials in parallel.

Demonstrated capability to consistently deliver clinical trials.

Demonstrated capability to effectively communicate and engage with sites and sites personnel.

Demonstrated problem solving capability.

Required Skills:

Preferred Skills: