Sr CRA

Job Description

Senior Clinical Research Associate

We are seeking a dedicated Senior Clinical Research Associate who will be responsible for performance and compliance for assigned protocols and sites. This role offers the opportunity to work at the forefront of research, delivering innovative health solutions that advance the prevention and treatment of diseases in people.

Responsibilities

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participate & provide inputs on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected.
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Work in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contribute strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Support and/or lead audit/inspection activities as needed.
• Follow the country strategy defined by CRD and CRA manager, contribute to the identification of new potential sites and work closely with them to develop strong clinical research capabilities.
• Mentor / buddy junior CRAs on process/study requirements and perform co-monitoring visits where appropriate.
• Perform Quality control visits if delegated by other roles and trained appropriately.

Qualifications

Required

• Experience in clinical research, preferably as  Sr CRA.
• In-depth understanding of the study protocol and related procedures.
• Ability to manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Strong communication skills to effectively communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Ability to identify, assess and resolve site performance, quality or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

Preferred

• Experience in mentoring / buddying junior CRAs on process/study requirements and performing co-monitoring visits where appropriate.
• Experience in contributing to the identification of new potential sites and working closely with them to develop strong clinical research capabilities.
• Experience in supporting and/or leading audit/inspection activities as needed.

Experience Requirements:

Required:

• Min. 8-10 years of direct site management (monitoring) experience in a bio/pharma/CRO.  

Educational Requirements:

Preferred:

• Masters in Pharmacy/Science.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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