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Medical Monitor at Peachtree BioResearch Solutions
Job details
Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value.
The Medical Monitor at Peachtree wears a few hats and will provide leadership / therapeutic area medical expertise in the development of clinical research strategic programs for Peachtree projects. The Medical Monitor will act as a medical resource to the company as a whole and particularly to the clinical operations and medical departments to support protocol / Clinical Investigation Plan (CIP) development, safety management of adverse events, subject screening and protocol / CIP management compliance, formal training or ongoing discussions with investigators, and internal or external training of Peachtree BioResearch Solutions or site staff in the MM therapeutic or development area of expertise.
A Few Responsibilities:
- Work closely and cooperatively with sponsors and research centers to ensure proper contributions to the global development of new products / devices.
- Participate in developing overall clinical strategies throughout the course of a study and provide medical input throughout the development process.
- Assist in writing and developing clinical protocols / CIPs.
- Review data management specifications to confirm collection of critical endpoint variables.
- Serve as clinical author in regulatory filings.
- Review safety data and safety summaries.
- Monitor incoming Safety Events, conduct follow-up necessary to complete information, and ensure that Safety Event information is forwarded to the Sponsor.
- Serve as medical liaison between stakeholders
- Attend necessary Sponsor/Principal Investigator (PI) meetings.
- Develop the Safety and Medical Monitoring Plan draft for review by the Sponsor
- Review Clinical Study Reports to ensure information is accurate and comprehensive providing a clear profile of the study results.
- Support bid defense efforts in clinical or regulatory areas of expertise.
Requirements:
- M.D., D.O., or equivalent
- CNS / Neuroscience expertise
- Experience working on complex clinical trials
- Experience and training on FDA regulatory requirements, GCP/ICH guidelines, and medical terminology related to clinical trials
- Ability to work independently, respond rapidly to changes, and work cooperatively with internal and external teams
- Medical, Dental, Vision, Life, Disability coverage
- 20 days PTO + PTO rollover + 13 paid holidays
- 401(k)
