The Clinical Research Project Manager position is an excellent opportunity for an individual who is interested in assisting a fast-emerging biopharmaceutical company conduct unique first-in-human, clinical research trials with multiple therapeutics. You will work under general supervision to manager a number of clinical research studies and manages data collection and submissions for multiple clinical trials. This position entails a high volume of document control and data abstraction; no patient contact.
Principal Duties And Responsibilities
The following duties will be performed under general supervision by the VP of Research and Manufacturing:
· Manage several ongoing and future clinical research project
· Write clinical research protocols
· Monitor and evaluate protocol compliance
· Manage data collection via chart abstraction and submit data
· Write informed consent documents
· Monitor and report adverse events as required by institutional/federal regulations
· Prepare submission of protocol revisions and safety reports to the IRB
· Prepare annual progress reports for IND and IRB renewal of ongoing studies
· Organize monitoring visits as requested by sponsors and make data corrections as required by monitor
· Resolve data discrepancies
· Assess impact of new risk information on consent documents and revise appropriately
· Exercise sound judgment in making critical decisions
Skills/Abilities/Competencies Required
· Careful attention to detail
· Good organizational skills
· Ability to follow directions
· Good communication skills
· Computer literacy
· Working knowledge of clinical research protocols
· Ability to demonstrate respect and professionalism for subjects’ rights and individual needs
Education
· Bachelor’s degree required.
· Minimum 2 years of relevant experience
Primary Location
Remote
Job
Research-Management
Organization
ZEO ScientifiX
Seniority Level
Mid-level Associate
Industry
Employment Type
Full-time
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