Senior Clinical Research Associate

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

PXL FSP has an exciting opportunity for a Senior CRA !

The Senior Clinical Research Associate is responsible for the following:

Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Key Accountabilities:

Site Management 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:

- Data generated at site are complete, accurate and unbiased.

- 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.

Team Development and Support
- 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.

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

- Contributes to initiatives and projects adding value to the business

- Performs co-monitoring as appropriate

Compliance with Parexel Standards

• Comply with required training curriculum

• Complete timesheets accurately as required

• Submit expense reports as required

• Update CV as required

• Maintain a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements

Skills:

• 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 wo