Responsible for assisting study team in conducting clinical trials in various therapeutic areas. Contributes to clinical research study development, implementation, conduct, and management.
ESSENTIAL FUNCTIONS PERFORMED
- Contribute to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.
- Assist in developing and overseeing study operational plan(s).
- Contribute to study team for trial start-up, conduct, and close-out activities according to industry and corporate standards.
- Participate in study data review and assist with patient outcome narrative writing and other data review activities as assigned.
- Participate in initiation, training and monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols; take ownership for data completion and accuracy.
- Contribute to creation of study documentation including clinical protocols, study tools, informed consent, investigator brochures, and clinical study reports.
- Perform other related duties and tasks, as required.
SUMMARY OF MINIMUM QUALIFICATIONS
- BS in Science, Life Science or related field a plus
- 1-3 years experience in medical device, pharmaceutical drug development, biotech or CRO industries monitoring and managing clinical trials
- Experience complying with GCP, ICH, ISO and FDA regulatory requirements
- Willing to be held accountable for deliverables
- Must be highly organized and detail oriented
- Experience interfacing with multiple vendors/contractors
- Proven ability to handle multiple projects and changing priorities
- Must be results-driven and exhibit a sense of responsibility and outcome ownership
- Clear and concise in verbal and written communication, fosters smooth flow of
timely and relevant information
- Strong initiative and positive attitude
- Ability to travel to clinical sites, domestic and foreign, up to 25%.
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