Sr. CRA - Clinical Research Associate

Job Description
Sr CRA- Responsibilities

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

- Gains an in-depth understanding of the study protocol and related procedures.

- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

- Participates & provides inputs on site selection and validation activities.

- Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected.

- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.

- Works 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.

- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

- Contributes 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.

- Supports and/or leads audit/inspection activities as needed.

- Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

- Could perform Quality control visits if delegated by other roles and trained appropriately.

CORE Competency Expectations:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Demonstrated ability to mentor/lead.

- Hands on knowledge of Good Documentation Practices.

- Proven Skills in Site Management including independent management of site performance and patient recruitment.

- Demonstrated high level of monitoring skill with independent professional judgment.

- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices

- Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.

- Experience with conducting site motivational visit designed to boost site enrollment.

- Capable of managing complex issues, works in a solution-oriented manner.

- Performs root cause analysis and imple