Senior Clinical Research Associate

---

Job description

As a Senior Clinical Research Associate (SCRA) at Parexel FSP you will be joining a team with a wide variety of experiences and knowledge. We're looking for people like you who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

You will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on oncology studies that deliver real impact.

Parexel FSP will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers.

If impact, flexibility, and career development appeal to you, Parexel could be your next home.

Position Purpose:

The Senior Clinical Research Associate (SCRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Primary Duties:

· Coordinates & manages various tasks to achieve Site Ready.

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

· Performs remote and on-site monitoring & oversight activities using various tools.

· Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records visit & non-visit contact reports.

· 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.

· Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and various other systems.

· Supports and/or leads audits/inspection activities as needed.

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

Skills and Education:

· B.A./B.S. preferred with a strong emphasis in science and /or biology.

· Minimum 4 years of direct site management & monitoring experience gained within bio/pharma/ or CRO required.

· 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.

· Fluent in local languages and English (verbal and written) and excellent communication skills.

About Parexel FSP:

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

For an immediate interview please contact the job poster.