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 Job #02962 Email this job to a friend
About our client
Our client is an early-stage biotech company, focused on development of drugs combined with a unique delivery system in the treatment of pulmonary illnesses.
Position Location
Clinical Research Manager Cape Canaveral, Florida (Orlando Area)
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Manage clinical research programs
2) Ensure compliance with all SOPs for clinical research programs
3) Oversee the updating of documents and the development of new SOPs
4) Communicate clinical research plans/procedures to program members
5) Ensure staff members receive appropriate as well as updated training
6) Create and maintain SOPs for program activities
7) Compile and prepare study-subject data for publication
8) Ensure study protocols are maintained and adhered to by all staff members
9) Manage study subject recruitment and process flow
10) Prepare and maintain all regulatory (IRB and FDA) paperwork
11) Perform research studies (as needed)
12) Obtain samples and administer procedures based on study protocols
13) Oversee study subject scheduling and coordination of clinical care
14) Report and attend to any adverse events with study subjects
Requirements
1) Bachelor’s degree (or higher)
2) 8+ years of experience in clinical research
3) Expertise in field monitoring
4) Experience in project management and budgeting
5) Experience in writing key clinical documents

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