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Senior Clinical Research Coordinator – $1500 Sign-on Bonus!

  • Permanent
  • Anywhere

Website The Ohio State University Wexner Medical Center

The Ohio State University Wexner Medical Center

Company : The Ohio State University Wexner Medical Center

Country: United States

Location : Columbus, Ohio

Post: Wed, 01 Feb 2023 20:44:52 GMT

Expires: Wed, 01 Mar 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Job Description Summary

Senior Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Clinical Trials Management Organization for the Department of Emergency Medicine; oversees, implements & coordinates conduct of daily activities of research studies; serves as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies; recruits, interviews and promotes study to eligible patients; educates patients and families of purpose, goals, and processes of clinical study; leads patient 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 patient care appointments, procedures, & other diagnostic testing; monitors patients for adverse reactions to study treatment, procedure 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, and analyzing clinical research data; assists with activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; participates in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participates in internal quality assurance audits; participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists with preparation and submission of publications, research reports, and grant proposals.

Essential Duties

60%: Plans, implements, coordinates and performs daily clinical research activities in accordance with approved protocols; oversees, evaluates and revises processes to identify, recruit and enroll patients into clinical studies; serves as primary reviewer of patient records including new patient admissions or readmissions, outpatient and/or emergency room visits to assess and identify patients who may meet criteria to be considered for inclusion in a clinical research study; recruits, interviews and promotes study to eligible patients; educates patients and families of purpose, goals, and processes of clinical study; leads patient enrollment activities and ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements; ensures initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol; facilitates collection, processing & evaluation of biological samples, as well as scheduling and coordinating medical procedures & diagnostic testing; coordinates and documents care of patients; participates in evaluating patients for compliance related to protocol; monitors patients for adverse reactions to study treatment, procedure 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.

15%: Participates in collecting, extracting, coding, and analyzing clinical research data; reviews research data to ensure validity and discover inconsistent or inaccurate data; assists with development of clinical research study database; compiles and enters clinical research data into study database; generates reports; assists with writing manuscripts & articles for publication and presentation.

10%: Participates in planning and developing of new clinical research projects; assists Principal Investigator with preparation and submission of national and local grant submissions to secure continued and additional funding of clinical research projects; contributes to development of plans to meet requirements of new clinical trials; assists with planning and development of clinical study processes.

10%: Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; prepares and participates in study monitoring activities; participates in planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; completes case report forms.

5%: Attends departmental meetings; attends national professional and scientific conferences to continue professional development; completes special projects as required.

Minimum Education and Skills/Experience Required/Desired

Bachelor’s Degree in biological sciences, health sciences or other relevant field or an equivalent combination of education and experience required; three to five years’ experience in a clinical research capacity conducting clinical research studies required; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in Emergency Medicine preferred; clinical research certification from an accredited certifying agency required; computer skills required with experience using Microsoft Software applications desired. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

Regular 40 First Shift

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