Clinical Research Associate

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%.