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Job Title:
Clinical Research Assistant
Department:
Medicine | Psychiatry
Clinical Research Assistant to assist and support scientific investigation for the State of Ohio Adversity and Resilience (SOAR) study in Ohio families across the state, as directed by the Department of Psychiatry and Behavioral Health.
The role entails significant travel, constituting approximately 50% of the position's responsibilities. The incumbent will be required to embark on trips involving overnight stays, spanning multiple nights, to various cities across Ohio. Flexibility in scheduling is essential, as the nature of the position will require occasional weekend work.
The SOAR team will interact and enroll participants from across the state of Ohio with a Mobile Unit, spending 2-3 months in each location: Northern Ohio (Mansfield, Youngstown), Eastern Ohio (Cambridge Area), and Southern Ohio (Jackson area). Each CRA will be on 1 of 3 teams who will travel with the Mobile Unit and whose schedule will either be three days on, four days off, or one week on, one week off. Hotel and travel costs will be covered.
the Clinical Research Assistant recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of participant appointments, procedures, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; assists with monitoring patients for adverse reactions to procedures 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 evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data; generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements; summarizes data for inclusion in grant proposals and manuscripts; prepares research progress reports; assists principal investigator with the preparation of publications, manuscripts, articles, posters, and abstracts; conducts library research on requested topics through researching current literature; oversees and maintains accurate records of laboratory activities; assists with training of junior research staff, and undergraduate and graduate students in research methods and equipment operation; sets up and operates laboratory equipment; monitors research supply, including specimens, inventory and initiates procurement requests as needed.
MINIMUM REQUIRED QUALIFICATIONS
Bachelor’s Degree in Biological Sciences, Health Sciences or medical field, or equivalent combination of education experience required. 2 years of relevant experience required. 4-6 years of relevant experience preferred.
Additional Information:
Assists and supports scientific investigation to study State of Ohio Adversity and Resilience (SOAR) in Department of Psychiatry and Behavioral Health.
75%: Implements, coordinates and performs daily clinical research activities in accordance with approved protocols; travels to mobile testing sites two weeks per month, including time away from home (e.g., Jackson, Cadiz, Youngstown, Lima) for 3-5 nights at a time; recruits, interviews and enrolls patients; participates in local recruiting events to highlight the SOAR study (at ADAMH boards, county fairs, school rallies); obtains informed consent (and teen assent) and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of the SOAR study; ensures appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol; sends appropriate reminders (texts/calls) to families for upcoming visits; coordinates scheduling and follow-through of diagnostic, MRI, EEG testing; collects and documents medical histories; participates in the collection, processing & evaluation of biological samples, including blood draws (phlebotomy training encouraged, but not required); administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; cares for equipment used in assessments (EEG, MRI, neuropsychological) in accordance with specified procedures; supports administration and processing of coordinates and documents care of patients; assists with monitoring patients for adverse reactions to study procedures 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 evaluating patients for compliance related to protocol.
10%: Assists with collecting, extracting, coding, and analyzing clinical research data; compiles and enters clinical research data into study database; generates reports and reviews to ensure validity of data; assists with development of clinical research study database; assists with writing sections of manuscripts, articles and other media for publication and presentation.
10%: Supports completion of 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; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; 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.
Location:
Research Administration Building (0200)
Position Type:
Regular
Scheduled Hours:
40
Shift:
First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
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