Proclinical is seeking a part time Medical Monitor Consultant for a leading biopharmaceutical company. This is a contract role with the opportunity to be fully remote.
The successful candidate will be responsible for ensuring the safe conduct of clinical trials and will play a key role in communicating with the medical team, CRO, and study sites. The Consultant will be responsible for protocol and document review, CRO communication, site engagement, and coordinating site visits. Additionally, the Consultant will participate in study team meetings and review data for quality control and accuracy.
Must be eligible to work in the US.
Job Responsibilities:
- Medical Monitoring Activities: Oversee medical monitoring activities to ensure patient safety and adherence to the study protocol.
- Oversight of Study Conduct and Lead Medical Monitoring Meetings: Lead medical monitoring meetings to review safety data, discuss adverse events, and develop action plans.
- Participate in Meetings with Medical Team, CRO, and Sites: Participate in meetings with the medical team, CRO, and study sites to ensure effective communication and coordination.
- Protocol and Other Pertinent Document Review in a Timely Fashion: Review study protocols, case report forms, and other relevant documents to ensure compliance with regulatory requirements.
- CRO Communication: Communicate with the CRO to ensure that the study is conducted in compliance with the study protocol.
- Engage Sites and Coordinate Site Visits: Engage with study sites to ensure adherence to the study protocol and coordinate site visits to ensure site readiness and compliance.
- Participate in Study Team Meetings: Participate in study team meetings to provide updates on medical monitoring activities and to ensure effective collaboration across the team.
- Data Review and Data Cleaning: Review study data to ensure data quality and accuracy, and to coordinate data cleaning activities with the study team.
Skills and Requirements:
- MD or equivalent degree.
- 5+ years of experience in clinical research, with 2+ years of experience in medical monitoring.
- Knowledge of ICH-GCP, FDA, and other regulatory requirements.
- Strong leadership and interpersonal skills.
- Excellent communication skills.
- Attention to detail and ability to work in a fast-paced environment.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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