Clinical Research Associate
- Experience Level
- Experienced (non-manager)
eople don’t come to PRA to witness the future of clinical development, they come to shape it. With an average of more than 6 former employees returning to PRA each month we can confidently say that the grass is greener at PRA. Come join the movement and discover your passion, your purpose, your PRA.
This is an exciting and rare opportunity to join our expanding team of Regional Clinical Scientist embedded in a sponsor at the forefront of ground breaking research within rare diseases. The Clinical Scientist will work with the Medical Lead/Lead Clinical Scientist and provide scientific, clinical, and operational review and input from ongoing early and late stage clinical trials with an emphasis on protocol-specific, in-life clinical data monitoring activities.
Work with the Study Medical Monitor/Study Clinical Scientist and provide scientific and clinical support from ongoing early and late stage clinical trials with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will also serve as a point of contact for CROs,investigators and study staff in day-to-day safety monitoring under the guidance of the Study Medical Monitor. This individual will report into Global Clinical Operations , and will interface directly with the Study Clinical Scientist and other cross-functional team members (including Clinical Development, Global Clinical Operations, Data Management, Biometrics, Patient Safety, Clinical Pharmacology and Biomarkers,) to support clinical study execution and clinical data monitoring.
• Support Medical Lead/Lead Clinical Scientist with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety.
• Provide clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
• Contribute to ICFs, training documents, literture reviews and other clinical and regulatory documents under the direction of the Medical Lead/Lead Clincal Scientist.
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
• Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
We're looking for someone who has;
- Experience in analysis and interpretation of clinical data (including safety and efficacy); working knowledge of GCP and clinical trial execution.
- Experience working with clinical trial sites.
- Experience in all stages of drug development
- Ability to make independent, timely and appropriate decisions.
- Ability to handle multiple projects at a time and have a strong attention to detail Excellent oral and written communication skills and solid computer/analytical skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
In additional to promoting a healthy work-life balance, excellent remuneration and benefits package, our commitment to our staff is only surpassed by our commitment to advancing treatment options available to patients: We understand the importance of supporting and investing in our people. With 20% of our employees promoted last year, we don’t need to tell you that your career will thrive at PRA. We know it. And we can prove it. As we grow, so will you. Come discover your PRA.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.