About The Position

Coordinates non-therapeutic clinical research protocols, such as minimal-risk, survey, and chart-review studies, under the direction of the principal investigator and/or supervisor and in compliance with regulatory laws and institutional guidelines. May assist with complex interventional, therapeutic, or greater-than-minimal-risk studies under direction, but is not responsible for those studies overall. Screens, enrolls, and recruits research participants; coordinates schedules and monitors research activities and participant involvement; recognizes and appropriately reports adverse events, protocol deviations, and other unanticipated problems; collects, abstracts, and enters research data; and performs assigned administrative and regulatory duties. Some travel may be required. Protocol development and maintenance duties may include managing protocol documents and processes through editing, amendments, proofing, coordinating study logistics such as data collection booklets and use of the CRU, and verifying content against institutional and federal standards. The role may also prepare Institutional Review Board submissions and communicate with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and performs other assignments as warranted and assigned. The selection process may include an optional OnDemand pre-recorded interview. Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.

Requirements

  • High school diploma with at least 3 years of experience; or an associate's degree, college diploma, or certificate program with at least 1 year of experience; or an associate's degree in Clinical Research from an accredited academic institution without experience; or a bachelor's degree.
  • Experience, where required by the applicable education pathway, should be in a clinical setting or a related area.

Nice To Haves

  • Graduate or diploma from a study coordinator training program.
  • One year of clinical research experience.
  • Medical terminology course.

Responsibilities

  • Coordinate non-therapeutic clinical research protocols under the direction of the principal investigator and/or supervisor, in compliance with regulatory laws and institutional guidelines.
  • Assist with complex clinical research studies under direction, without overall responsibility for those studies.
  • Screen, enroll, and recruit research participants.
  • Coordinate schedules and monitor research activities and participant involvement.
  • Recognize and appropriately report adverse events, protocol deviations, and other unanticipated problems.
  • Collect, abstract, and enter research data.
  • Perform assigned administrative and regulatory duties related to studies.
  • Manage protocol documents and processes, including editing, amendments, proofing, study logistics coordination, and verification against institutional and federal standards.
  • Prepare Institutional Review Board submissions.
  • Communicate with study sites and/or federal agencies regarding study status changes.
  • Participate in other protocol development activities and perform other assignments as warranted and assigned.

Benefits

  • Multiple medical plan options.
  • Dental coverage through Delta Dental or a reimbursement account for flexible coverage.
  • Vision plan with a national network.
  • HSA and FSA pre-tax savings options for eligible expenses.
  • Competitive retirement package.
  • Competitive compensation and comprehensive benefit plans.
  • Continuing education and advancement opportunities.
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