Medical Monitor - Clinical Research (Medical Degrees Only)
Medical Monitor - Clinical Research (Medical Degrees Only)
Piper Companies
Silver Spring, MD
See who Piper Companies has hired for this role
Piper Companies (Health & Sciences) is seeking motivated candidates for a Medical Monitor and/or Safety & Pharmacovigilance Specialist opportunity in the Montgomery County, MD area to support a well-established research organization focused on providing biopharmaceutical development support, health information services, and health & environment assessments for commercial and government clients.
- Ensure compliance with Food and Drug Administration and World Health Organization regulations.
- Investigate, Manage and process all Serious Adverse Events (SAEs) for assigned clinical research trials
- Track and process assigned pharmaceutical and Data Management Center (DMC) queries
- Generate specified data reports from the safety database as requested
- Assist with the development of Investigator Brochures (IB) and provide direction to clients
- Process and edit safety narratives for Investigational New Drug (IND) and Non-IND Adverse Event (AE) cases as required
- Distribute Safety Information according to project specific requirements
- Maintain document control for safety & pharmacovigilance electronic files, perform file case searches & queries, maintain trial databases and ensure all files are up to date and accurate
- Utilize databases to track, manage and control issued documents and assign tracking numbers
- Assist in the preparation of contract-required reports
- Utilize MedDRA & WHODRUG codes for reporting
- Perform quality audits on AE reports
- 3+ years of experience in clinical research and/or bioethics with preferred experience directly related to safety & pharmacovigilance
- Knowledge of regulations, policies and reporting relevant to the protection of human subjects in clinical trials: GCP, IRB, FDA, SAE reporting, IND applications
- Doctor of Medicine (MD) degree
- Salary Range: $100,000-$150,000 based on relevant experience
- Full Benefits: Health, Vision & Dental Insurance, 401K
-
Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Other -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Piper Companies by 2x
See who you knowGet notified about new Monitor jobs in Silver Spring, MD.
Sign in to create job alertSimilar jobs
People also viewed
-
Support Staff-Cafeteria Monitor-PT/NBN (3.5 Hrs.)
Support Staff-Cafeteria Monitor-PT/NBN (3.5 Hrs.)
-
Data Coordinator
Data Coordinator
-
Information Technology Help Desk
Information Technology Help Desk
-
Customer Support Specialist
Customer Support Specialist
-
VRU Technician II
VRU Technician II
-
Care Navigator
Care Navigator
-
Safety Monitor Technician, Full-Time Days, Baptist IT Center
Safety Monitor Technician, Full-Time Days, Baptist IT Center
-
Medication Technician
Medication Technician
-
Cardiac Monitor Technician - Med/Surg - Canonsburg Hospital - Full Time
Cardiac Monitor Technician - Med/Surg - Canonsburg Hospital - Full Time
-
CLASSROOM MONITOR
CLASSROOM MONITOR
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub