OPS Research Assistant, Vascular Surgery

Apply now Job no: 541299
Work type: Temp Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Biology/Life Science, Social/Behavioral Science
Department:29141900 - MD-SURGERY-VASCULAR

Classification Title:

OPS Research Assistant
Classification Minimum Requirements:

Associate’s degree or an allied health professional degree in an appropriate area and one year of
relevant experience; or an equivalent combination of education and experience.
Job Description:

Coordination of Protocol Subjects & Data Collection

  • Performs subject screening and consent for clinical protocols under direction of Principal Investigator.
  • Serves as patient resource and educator for information regarding the study or clinical symptoms.
  • Prepares and ships central laboratory samples as per protocol requirements.
  • Collects baseline and follow-up data from the medical record.
  • Documents findings in appropriate source records and case report forms.
  • Schedules and attends clinic appointments for patients as required by protocol.
  • Communicates with nursing staff and OR Staff about patient care according to protocols.
  • Assists with operating room protocol requirements where appropriate.
  • Records patient symptoms and adverse events in conjunction with care providers.
  • Reports and follows up adverse events and serious adverse events, after discussion with Principal
  • Investigator, to sponsor and Investigational Review Board as required by protocol
 

Coordination of Protocol Compliance

  • Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct.
  • Coordinates and maintains HIPAA compliance for assigned studies.
  • Communicates with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.
  • Interacts with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies.
  • Coordinates efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines

 

Research Support

  • Assists medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols.
  • Helps with protocol development and protocol endpoints to ensure statistical and clinical relevance of studies.
  • Assesses clinical needs by performing literature review and discussion with faculty advisors within Division.
  • Prepares and submits filings of protocols to Investigational Review Board and Animal Care Committees as needed.
  • Designs Case Report Forms and Source Documents for clinical protocols where required.
  • Assists with grant development projects. Maintains awareness of Good Laboratory Practices as needed for preclinical studies within Division.
  • Assists with manuscript preparation and abstract submission for principal investigators.
  • Submits protocols to the RAC and IRB offices to assure compliance under the direction of the senior study coordinator.
  • Organizes and maintains regulatory files for clinical studies performed within Division.
  • Interacts with institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols.
  • Tracks the type of study services performed to ensure that they are compensated appropriately.
  • Performs billing review for study subjects.
  • Dispense human subjects’ payments to study participants
 
 
 
Expected Salary:

$16 - $18 per hour
Required Qualifications:
Associate’s degree or an allied health professional degree in an appropriate area and one year of
relevant experience; or an equivalent combination of education and experience.
Preferred:

 

  • Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.
  • Experience as research coordinator preferred.
  • Experience with patient data and/or databases.
  • Proficient time management skills and ability to successfully manage multiple studies.
Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume. 

Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: yes

 

Advertised: Eastern Daylight Time
Applications close: Eastern Daylight Time

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