Clinical Research Coordinator
- Location: Rochester, MN
- Posted: Jan 8, 2019
Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborates with research team to assess feasibility and management of research protocols. Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Provides education/training for others within the department. Performs administrative and regulatory duties related to the study as appropriate. 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. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participates in other protocol development activities and executes other assignments as warranted and assigned.
Candidate will also be trained in the Sensory Lab performing quantitative sensation tests (QSTs). QST is a psychophysical set of tests to ascertain the threshold of different modalities of sensation at specific anatomical sites. The QST technician must adequately explain, perform, observe, record, and manage a patient during intervals of one to two hours for the conduct of the QST session. The QST technician must be familiar with the nature of stimuli given, the algorithm of testing, basic aspects of underlying physiology of sensation and its derangement, and be able to generate preliminary impressions of results. She/he must take the necessary time to create an appropriate atmosphere for reliable testing and must pay close attention to ensure that the subject is cooperating and not distracted or drowsy. The technician will also recognize stimulus-response patterns which indicate distraction, drowsiness or perhaps even malingering. The position not only requires performing the testing but to make critical responses to the reactions of the patients.
Bachelor's degree required. Minimum of one year of experience in a clinical research setting or related field required. Completion of Mayo Clinic competency based assessment program will be required within one year of hire.
**Visa sponsorship not available for this position**
- Full Time