Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) 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 CRA at Parexel, you‘ll 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.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
- Innovative
- Problem-Solver
- Communicator
- Tech-Savvy
- Confident
- Independent
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Compensation
Competitive salaries and bonus structure based on individual metrics.
Responsibilities
The Early Clinical Development Senior Clinical Research Associate will have relevant Phase I experience, responsible for conducting monitoring activities for one or more client sponsored studies. The Sr. CRA functions as a member of the clinical study team and performs study monitoring according to Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and client Standard Operating Procedures (SOPs).
• Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs
• Responsible for monitoring clinical trial quality and site management for client sponsored studies that are not fully outsourced to a contract research organization (CRO)
• Conducts site qualification, initiation, interim, and close-out visits
• Ensures sites meet performance expectations related to recruitment, enrollment, and retention
• Reviews site source documentation, case reports, and verifies accurate data capture
• Ensures site regulatory files are current, and verifies the timely submission of study documentation (including safety reporting)
• Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol
• Identifies and records protocol deviations
Site Management
• Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up, conduct, and close out
• Builds and maintains professional relationships with site personnel
• Analyzes issues and uses sound judgment to make decisions and escalates study related issues as necessary
• Travels to clinical study sites as required, including remote or onsite visits globally
Skills:
• Analytical problem-solving experience, trouble shooting and resourcefulness
• Working knowledge of clinical drug development process
• Effective communication, interpersonal skills, and the ability to build relationships
• Familiarity with medical and clinical trial terminology
• Proficient in written and spoken English required
• Proficient in local language, as applicable, preferred
• Proficiency in widely used technologies
• Ability to learn client applications
• Travel to be inclusive of regional, national and international as required
Knowledge and Experience:
• Minimum of 5 years relevant industry experience
Education:
• Bachelor’s Degree or equivalent is required
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