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Clinical Research Associate - Orthopedics

Trinity Health Fort Lauderdale, FL
  • Posted: October 16, 2019
  • Full-Time

This person will be responsible for the conduct of multiple clinical research activities. Ideal candidate will have industry sponsored clinical trial experience and/or project management experience for investigator initiated projects. Person is able to work with minimal supervision and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits. Person will be responsible for leading and managing the project from the standpoint of clinical research activities. Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulations. Must adhere to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. Experience with clinical trials and industry sponsored studies preferred.

  • Help determine staff, facility, and equipment availability
  • Liaison with health-care professional/providers to determine best recruitment practices for study as needed
  • Schedule and/or coordinate pre-study site visits with Sponsor/CROs
  • Identify potential subjects from review of existing protected health information based on inclusion/exclusion criteria
  • Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study
  • Perform subject interviews and assessments at study visits for data required by protocol; assess and ensure subject safety throughout participation in trial
  • Conduct study procedures/interventions (appropriate licensure may apply)
  • Determine appointments per protocol; Schedule subjects for appointments
  • Extract data from source documents; Complete Case Report Forms (CRFs) or database entries; Audit for accuracy and correct CRFs; Resolve sponsor queries; Provide/create source documentation tools for subjects' charts/records
  • Contact outside health-care providers to obtain follow-up information; Communicate with subjects to obtain follow-up information
  • Monitor study team compliance with required study procedures and GCP standards
  • Record and document protocol deviations; Communicate with PI and Sub-Investigators about changes in the trial
  • In conjunction with the research pharmacist: Order and receive drug/device supplies; Dispense drug/device supplies (calculate dosage as needed) as directed by the CRC; Maintain files of drug/device dispensation, compliance and return
  • Ensure proper collection, processing, shipment of specimens, and documentation; Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings (appropriate licensure may apply)
  • Compose and submit continuing review/amendments/close-out information to the IRB; Schedule and prepare for monitor visits
  • Develop and implement teaching tools for subjects and families; Serve as an advocate for the subjects and their family
  • Maintain current knowledge of regulatory affairs and/or issues
Apply
Job Number: 00169454
Location: Ft. Lauderdale, FL
Organization Name: Holy Cross Hospital
Facility: HCHFL - Holy Cross Hospital
Employment Type: Full time
Shift: Day Shift
Hours: 40

Trinity Health

Address

Fort Lauderdale, FL
USA

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