Lead Clinical Research Coordinator

The Ohio State University
1dOnsite

About The Position

Lead Clinical Research Coordinator serves as primary resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Center for Clinical Research Management (CCRM) for the Department of Neurology, Division of Cognitive Neurology with a focus on memory disorders and neurodegenerative disease clinical trials; plans, implements & oversees daily conduct of protocol activities; serves as primary reviewer of patient records to assess & identify patients who meet criteria for participation in research studies in populations with cognitive impairment, mild cognitive impairment (MCI), Alzheimer’s disease, and related dementias, Huntington’s Disease (HD); recruits, interviews & promotes study to eligible patients; educates patients and families and/or caregivers of purpose, goals, & processes of clinical study; leads patient enrollment activities & ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements, including consent and assent processes appropriate for cognitively impaired participants; conducts standardized and protocol-specific cognitive testing for evaluation of participant eligibility and longitudinal assessment of cognitive outcomes across study visits; facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing commonly used in memory disorders trials (e.g., neuroimaging, biomarker collection); monitors patients for adverse reactions to study treatment or medication 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, & analyzing clinical research data, with particular emphasis on cognitive, functional, and behavioral outcome measures; monitors & ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations; participates in planning and preparing for external compliance, quality assurance & control reviews; participates in development of new research protocols and contributes to planning of goals to meet study requirements for memory disorders and aging-related research; works closely with principal investigators upon awarding of new protocols and recommends team assignments; assists with preparation and submission of publications, research reports, and grant proposals; trains, mentors, and supervises clinical research staff, providing leadership in cognitive assessment administration, protocol adherence, data quality, and regulatory compliance.

Requirements

  • Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
  • 3-5 years of relevant experience required.
  • Three to five years’ experience in a clinical research capacity conducting clinical research studies required
  • Three to five years of experience performing cognitive testing for research or clinical purposes required.
  • Computer skills required.
  • Clinical research certification from an accredited certifying agency required (ACRP or SOCRA).

Nice To Haves

  • Graduate degree (Master's or Doctoral) preferred
  • Experience in a progressively responsible management capacity in a medical research environment preferred
  • Experience or knowledge in neuromuscular diseases and disorders preferred.

Responsibilities

  • Serve as lead coordinator for memory disorders and neurodegenerative disease clinical trials within the Division of Cognitive Neurology
  • Conduct and oversee standardized cognitive and neuropsychological testing to determine study eligibility and support longitudinal data collection
  • Ensure high-quality, protocol-compliant data collection across cognitive, functional, behavioral, and clinical outcome measures
  • Recruit, consent, and retain participants with cognitive impairment, including engagement of caregivers and study partners
  • Provide day-to-day leadership through training, mentoring, and supervision of clinical research staff, with emphasis on cognitive testing competency and regulatory adherence
  • Collaborate closely with principal investigators, sponsors, and interdisciplinary teams to support successful trial execution
  • Maintain compliance with IRB, FDA, and sponsor requirements, and contribute to audits, publications, and grant-related activities

Benefits

  • Eligible Ohio State employees receive comprehensive benefits packages, including medical, dental and vision insurance, tuition assistance for employees and their dependents, and state or alternative retirement options with competitive employer contributions.
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