Hightop Health is a premier outpatient mental health group. We’re deeply entrenched in the communities we serve, and we work with patients across all acuities to support them on their unique mental health journey. Hightop Health is the umbrella group for the most reputable and integrative mental health clinics such as Psych Atlanta and Roots Behavioral Health.
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Job Title: Clinical Research Coordinator
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Reports to: Clinical Research Manager
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Location: Psych Atlanta, 1012 Coggins Place, Marietta, GA 30060
Responsibilities:
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Conduct all protocol required subject visits and complete all protocol required assessments including vital signs, lab sample collection, ECG collection, adverse event monitoring, concomitant medication monitoring, and other required assessments per protocol.
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Coordinate the flow of each protocol required visits with other staff and Principal Investigator as needed.
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Collect, process, and ship blood/urine specimens at scheduled subject visits per protocol and IATA guidelines.
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Administer questionnaires/diaries per protocol.
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Schedule all subject research visits and procedures consistent with protocol requirements.
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Ensures all clinical activities are carried out in accordance with established research protocols and standards and in compliance with all applicable laws, regulations, policies, and procedural requirements.
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Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
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Actively recruit potential subjects through local and central advertisements, chart reviews, and subject database reviews.
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Recruits and screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participants’ eligibility or exclusion.
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Accurately document information in all research charts based on GCP.
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Complete and maintain case report forms per FDA guidelines and review them against the subject’s chart for completeness and accuracy.
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Ensure that non-serious and serious adverse events are properly documented and reported.
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Ensure all concomitant medications are properly documented and reported.
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Receive, store and dispense all investigational product per protocol specifications and FDA regulations.
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Manage and record temperature logs for Investigational Product closet, refrigerator, and freezer daily.
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Receive and maintain all study related materials including, but not limited to lab kits, ECG machines, tablets, recruitment materials, etc.
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Destroy any unused study materials as specified by site SOPs and sponsor requirements.
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Completes all IRB and other regulatory submissions per GCP guidelines and IRB requirements.
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Completes and maintains all regulatory documents per FDA regulations for each assigned trial.
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Schedule, prepare for, and actively participate in site monitoring visits.
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Attend sponsor/ CRO meetings on and off site as required.
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Assist practice staff with all medical needs, including but not limited to blood pressure collections, ECG collection, lab specimen collection and processing.
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Administer injections for practice subjects as needed.
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Manager the proper handling of, packing of, and scheduling the pickup of biohazard per appropriate regulations.
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Schedule and monitor medical maintenance of all study equipment.
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Operate within the core values of respect and care for others.
Note: The employer reserves the right to change or assign other duties to this position
Qualifications:
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The right candidate has a minimum of 5 years’ experience in clinical research coordinating investigational clinical trials and is already familiar with clinical research workflows, regulatory requirements, and data collection and documentation practices.
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Must have GCP, IATA
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BLS/CPR training upon hire date
Education:
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BA/BS in business, social science, health science or related field required or BS in Nursing with current license.
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Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred either from Society of Clinical Research Professionals or Association of Clinical Research Professionals preferred.