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Receives direction from principal investigator supervisor or other staff involved in research protocol(s). Interacts with various departments within the institution. Works cooperatively with other investigators and personnel at all levels. Interacts with research participants other research centers and sponsoring companies to resolve problems and ensure efficient completion of research studies.
Position Overview: (Major Functions and NonEssential Functions):
Coordinates nontherapeutic (i.e. minimal risk survey chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional therapeutic greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens enrolls and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events protocol deviations and other unanticipated problems and reports appropriately. Collects abstracts and enters research data. Performs administrative and regulatory duties related to the study as assigned. Some travel may be required. ADDENDUM (if applicable) Protocol Development and Maintenance Activities Responsibilities may include but are not limited to: ongoing management of the protocol document and process through editing amendments proofing coordination of study logistics (i.e. data collection booklets use of CRU etc. and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned.
Additional Information:
Visa sponsorship is not available for this position.This position is not eligible for F1 OPT STEM extension.
Minimum Education and/or Experience Required: (Education Requirements and Experience):
HS Diploma with at least 3 years of experience OR Associates degree/college Diploma/Certificate Program with at least 1 year of experience Associates in Clinical Research from an accredited academic institution without experience OR Bachelors degree. Experience should be in the clinical setting or related experience.
Additional Experience and/or Qualifications: (Has Achieved Competency in the Following Areas Job Knowledge and Additional Considerations):
Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.
Licensure/Certification Required:
N/A
Required Experience:
IC
Full-Time