Clinical Research Coordinator

Hightop Health•Marietta, GA

25d•Hybrid

About The Position

Hightop Health’s clinical research program is dedicated to advancing mental health treatments through rigorous clinical trials. By participating in cutting-edge research, we develop and refine innovative therapies tailored to individual needs. For over 20 years, our clinical trials have helped develop the latest treatment options for various mental health conditions, ensuring the highest standards of care and driving continual improvements in the future of mental health care. Our Integrative Psychiatry services are designed to treat the whole person, optimizing our patients’ overall health and well-being while prioritizing comprehensive and compassionate care. Our advanced services include: Esketamine (Spravato™), Transcranial Magnetic Stimulation (TMS), Cognitive Behavioral Therapy Intensive Outpatient Programming, and IV Ketamine. We are seeking a dedicated Clinical Research Coordinator who is passionate about delivering high quality outpatient care, to join our research team in Marietta, GA! Clinic Location: Marietta, GA - 1012 Coggins Pl, Marietta, GA 30060 Full-Time; hybrid Hightop Health PERKS: Medical Benefits, robust Paid Time Off, Paid Holidays, Retirement Plan and more! Job Summary: The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct of multiple clinical research trials at Hightop Health. This role provides both administrative and clinical support for investigational studies, ensuring that research activities are performed safely, ethically, and in compliance with study protocols, Good Clinical Practice (GCP), FDA and other regulatory requirements, and Hightop Health policies. The CRC works closely with Principal Investigators, study sponsors/CROs, and the clinical care team to support protocol execution, subject safety, accurate data collection, and timely regulatory documentation.

Requirements

BA/BS in health science, social science, business, nursing, or related field required; OR BS in Nursing with current RN license, as applicable to Hightop Health needs and state regulations.
Current BLS/CPR certification required or obtained within a timeframe defined by Hightop Health.
Current GCP and IATA training required, with timely renewals per regulatory and Hightop Health requirements.
Minimum of five (5) years of experience in clinical research coordinating investigational clinical trials, with familiarity in research workflows, regulatory requirements, and clinical documentation practices.
Demonstrated experience conducting subject visits, collecting clinical data, handling lab specimens, and performing protocol-specific assessments.
Working knowledge of FDA regulations, ICH-GCP guidelines, IRB requirements, and HIPAA as they relate to clinical research.
Proficiency with electronic data capture systems (EDC), clinical trial management systems (CTMS), and standard office software (e.g., email, Microsoft Office).
Strong written and verbal communication skills; ability to explain complex information to participants and colleagues clearly and respectfully.
Highly organized, detail-oriented, and capable of managing multiple studies and priorities simultaneously.
Demonstrates professionalism, confidentiality, and discretion in all interactions.

Nice To Haves

Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) from recognized bodies (e.g., SOCRA, ACRP) preferred; willingness to obtain certification within a timeframe defined by Hightop Health is desirable.

Responsibilities

Coordinate and conduct protocol-required study visits for research participants, including completion of all protocol-specified assessments (e.g., vital signs, ECGs, lab collection, questionnaires) within defined time windows.
Ensure each study visit is conducted according to the approved protocol, investigator instructions, and site standard operating procedures (SOPs).
Support the PI in ensuring subject safety and data integrity throughout the course of each study.
Perform and document protocol-required clinical assessments such as vital signs, ECG collection, adverse event (AE) monitoring, and concomitant medication review, within scope of training and credentialing.
Collect, process, and ship biological specimens (e.g., blood, urine) per protocol and IATA guidelines, including proper labeling, handling, packaging, and documentation.
Administer protocol-specific questionnaires and diaries, providing instructions to participants and ensuring complete, accurate data capture.
Assist practice staff with clinical tasks as directed, including blood pressure collection, ECG collection, specimen collection and processing, and administering injections within scope and policy.
Manage and document the proper handling, packing, and scheduled pick-up of biohazard and regulated medical waste in accordance with applicable regulations and Hightop Health policies.
Accurately document study-related information in source documents and research charts, following GCP and Hightop Health documentation standards.
Complete, review, and maintain case report forms (CRFs/eCRFs) for accuracy and completeness; reconcile data against source documents and resolve queries in collaboration with the PI and sponsor/CRO.
Ensure timely and accurate documentation and reporting of all non-serious and serious adverse events (AEs/SAEs) and concomitant medications as required by protocol, sponsor, IRB, and regulatory requirements.
Maintain essential regulatory documents and study files in accordance with FDA regulations, GCP, sponsor expectations, and Hightop Health SOPs.