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
Hard working person with some experience prep in catering or food prep.
...local group in the Marlborough area. This 13 week assignment offers extension potential, a supportive team and guaranteed 40 hours. We pay our Registered Nurses hourly, ensuring they are paid for drive time in addition to mileage. The ideal RN will have 2+ years of home...
ProctorJob Location(s)US-NY-Old WestburyJob ID2024-3635DivisionCollege of Osteopathic Medicine# of Openings14Position TypeTemporary StaffTypeTemporary Part-TimeCategoryCollege of Osteopathic MedicineOverviewNew York Institute of Technology...
...Job Description The Sales Manager II generates maximum sales efficiencies, while maintaining or exceeding targeted Volume Per Guest... ...match and Stock Purchase options. Our Go Hilton Team Member Travel Program offers deeply discounted rates and 50% off at participating...
...We are seeking Attorneys based in White Plains or Long Island, NY, with experience in General Liability, Labor Law, or Medical Malpractice Defense. They offer a remote work environment, room for growth, and work-life balance. Qualifications: ~ Juris Doctor (J.D.)...