Clinical Research Senior Coordinator

at  The Ohio State University

HPC is a campus–wide initiative out of the Office of Research that connects assets to create diverse collaborative research teams with the goal of advancing the study of human performance with enhanced focus on performance optimization, mind-body wellness and human machine teaming. The collaborative aims to conduct life-changing human performance research, impactful community outreach, and enlightening educational programs and content to serve the local to global population.
The Clinical Research Senior Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Human Performance Collaborative and the Air Force Research Laboratory.

Responsibilities will include:

• Oversees, implements & coordinates conduct of daily activities of research studies; serves as primary reviewer of participant records to assess and identify participants who meet criteria for participation in principal investigator initiated clinical trials;
• Recruits, interviews and promotes study to eligible participants; educates participants of purpose, goals, and processes of clinical study;
• Leads participant enrollment activities and ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements;
• Facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of appointments & other testing;
• Monitors participants for adverse reactions to study treatment or procedure and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care;
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in collecting, extracting, coding, and analyzing clinical research data;
• Works with the PI on clinical trial activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations;
• Serves as a lead resource in planning, organizing and preparing for external compliance and quality assurance and control reviews;
• Actively participates in internal quality assurance audits and responsible for gathering and informing internal and external stakeholders on process improvement;
• Serves as a lead resource in the development of new research protocols and contributes to planning of goals to meet study requirements; works with the PI in the preparation and submission of publications, research reports, and grant proposals.

Minimum Education Required: Bachelor’s Degree in biological sciences, health sciences, psychology, neuroscience, or medical field or an equivalent combination of education and experience required;

EXPERIENCE AND QUALIFICATIONS:

Required: Minimum of 3 years of experience in basic science or clinical research.
Desired: Certified Phlebotomist desired;
4-6 years of relevant experience with recovery technologies (e.g. Photobiomodulation, Sauna, Cold Plunge, Float, etc.) desired;
Experience with wearable device technology (e.g. Fitbit, Apple Watch) desired;
Computer skill required with knowledge of database software applications desired (e.g. Smartabase);
Experience working with tactical populations (i.e. military personnel, police officers, firefighters, etc.)
Function: Research and Scholarship
Subfunction: Clinical Research
Career level: S3
Position will be located at the Air Force Research Laboratory in Dayton, OH with occasional travel to Columbus OH.

• Oversees, implements & coordinates conduct of daily activities of research studies; serves as primary reviewer of participant records to assess and identify participants who meet criteria for participation in principal investigator initiated clinical trials;
• Recruits, interviews and promotes study to eligible participants; educates participants of purpose, goals, and processes of clinical study;
• Leads participant enrollment activities and ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements;
• Facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of appointments & other testing;
• Monitors participants for adverse reactions to study treatment or procedure and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care;
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in collecting, extracting, coding, and analyzing clinical research data;
• Works with the PI on clinical trial activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations;
• Serves as a lead resource in planning, organizing and preparing for external compliance and quality assurance and control reviews;
• Actively participates in internal quality assurance audits and responsible for gathering and informing internal and external stakeholders on process improvement;
• Serves as a lead resource in the development of new research protocols and contributes to planning of goals to meet study requirements; works with the PI in the preparation and submission of publications, research reports, and grant proposals