Clinical Research Coordinator ALS & Neuromuscular Disease

Mayo Clinic•Jacksonville, FL

About The Position

We are seeking an experienced candidate to join a highly committed team focused on advancing care for patients with ALS and other neuromuscular diseases. This is an opportunity to make an immediate and meaningful impact in the fight against terminal illness, working alongside attentive, deeply involved Principal Investigators who value collaboration and excellence. The ideal candidate will bring prior experience coordinating clinical trials and a strong ability to step in quickly, contribute from day one, and navigate the unique challenges and rewards of research in terminal illness. Job Duties: 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. Please note that this position is not available for visa sponsorship. Mayo Clinic does not participate in the OPT STEM program.

Requirements

HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
Experience should be in the clinical setting or related experience.

Nice To Haves

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

Responsibilities

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.
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.
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.