Clinical Research Coordinator - Neurology
About The Position
This role will be supporting non-cancer Neurology clinical trials with an emphasis in, but not limited to, ALS studies. Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Gives direction to and works cooperatively with other research staff. Collaborates 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: 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. 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. During the selection process you may participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question – Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps.
Responsibilities
- Independently coordinates complex 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.
- 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
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
