Senior Clinical Research Associate - FSP
- Employer
- Parexel
- Location
- United Kingdom - Homebased
- Salary
- Excellent pay and benefits
- Start date
- 22 Jul 2021
- Closing date
- 21 Aug 2021
View more
- Discipline
- Clinical Research, Clinical Research Associate, Clinical Study Manager, R & D , Biotechnology, Scientific
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Duration: Permanent
Home based - UK.
Open on TA area.
Sponsorship is NOT available.
Everything we do has the potential to impact patient lives, and our Senior Clinical Research Associates (SRA) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client, and site satisfaction.
As a 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 to take the initiative to do things better and smarter people 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.
Position Purpose:
This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites. This role may provide operational input to clinical study teams as directed.
Responsibilities may include:
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are with applicable local regulatory requirements and ICH GCP guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
- Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
- Completes monitoring activity documents as required by SOPs or other contractual obligations.
- Escalates site and trial related issues per SOPs until identified issues are resolved or closed
- Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
- Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
Experience:
- 3 + years of clinical monitoring experience required.
- Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
- An advanced degree (eg, MS, MBA, PharmD, etc.) preferred.
- Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visits.
- Monitoring such as: phase I, remote, Oncology, General Med, Immuno, etc.
About ExecuPharm/PAREXEL FSP
A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.
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 telephone interview please contact the job poster.
Company
Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.
Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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