Clinical Research Coordinator II

Sunstone Therapies Clinical Research Coordinator II Rockville, MD · Full time This is a critical role responsible for the hands-on execution and coordination of clinical research studies at Sunstone. With direct involvement in patient care and study operations, the Senior Clinical Research Coordinator ensures the smooth conduct of research trials, including patient recruitment, visit coordination, informed consent, data collection, regulatory compliance, and specimen processing. This role bridges the gap between clinical operations and research execution, playing a key part in maintaining the integrity and success of Sunstone’s clinical research program. The Senior CRC will collaborate closely with the regulatory affairs specialist, data manager, MAs, therapists, raters, and all other clinical research staff. About Sunstone Therapies We exist to accelerate on-the-ground learning and operations necessary to approve and scale psychedelic therapies in the medical setting. The Sunstone team was brought together by shared compassion for those who suffer and a genuine wish to broaden their access to treatment. Our backgrounds in medicine, business, and design provide us with unique perspectives and skills necessary to define the standards of patient experience. Our values guide us in everything we do: Bring Forth Healing + Work with Rigor + Care for the Team + Learn and Grow + Innovate Boldly. In service to Sunstone’s vision of Whole Person Healing for All, all of our team members play a key role in Sunstone’s ability to deliver on its vision with Love and Rigor. Description Job Date: Jun 2026 FLSA: Exempt FTE: Full-time Job Title: Clinical Research Coordinator II Location: Onsite in Rockville, MD Schedule: Variable schedule between 7:45 am - 6pm Generally 8 hours per day Mon-Fri, periodic Saturday shifts Reports To: Practice Administrator Supervises: n/a Duration: on-going Job activities include but are not limited to: Collaborating with principal investigators and other research staff to develop, implement, and monitor clinical research protocols. Timely reporting of adverse events to investigators and research team leadership. Coordinating all aspects of clinical research studies, including participant recruitment, screening, enrollment, and follow-up visits. Performing clinical procedures, including taking vitals, drawing and processing blood samples, conducting EKGs, conducting full informed consent discussions, collecting concomitant medications and medical history, and ensuring participants understand study procedures and potential risks. Assisting Clinical Schedulers with scheduling study visits, procedures, and assessments according to protocol requirements and participant availability. Working closely with the Data Manager to ensure accurate and efficient collection, recording, and management of research data using electronic data capture systems. Working closely with the Regulatory specialist to maintain study documentation, case report forms, and study logs, in compliance with FDA, GCP, and institutional guidelines. Act as the primary point of contact for study participants, addressing concerns and ensuring a positive experience. Coordinating study-related activities with external stakeholders, including sponsor representatives, contract research organizations (CROs), and regulatory authorities. Educating investigators on the operational and logistical details of clinical trials. Ensuring compliance with Good Clinical Practice (GCP) guidelines, federal regulations, and institutional policies throughout the conduct of clinical trials. Participating in study monitoring visits, audits, and regulatory inspections, ensuring timely resolution of any findings. Training new Clinical Research Coordinators (CRCs) and support staff. Required skills, experience and competencies: Education: RN (ADN or BSN) or Bachelor’s degree (BS/BA) in any discipline Experience: Minimum 3 years of clinical research coordination experience Minimum 1 year of sponsor-based research experience At least 1 year of phase II or III clinical trial experience At least 2 years human subjects research experience Strong phlebotomy/blood draw skills Strong understanding of clinical research methodology, regulatory requirements, and ethical principles governing human subjects research. Excellent interpersonal, communication, and organizational skills. Ability to work independently and collaboratively in a fast-paced research environment. Proficiency in using electronic health record systems and data management software. Commitment to maintaining patient confidentiality and privacy. Flexibility to adapt to changing priorities and project timelines. Preferred skills, experience and competencies: Therapeutic area: neurology, psychiatric, or oncology clinical trial experience highly preferred. Clinical skills: Full vital signs collection Specimen processing EKG performance and basic interpretation Full informed consent administration Concomitant medication collection Medical and psychiatric history collection Physical Requirements A large percentage of time performing computer work is required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Compensation and Benefits Sunstone Therapies offers a competitive salary package commensurate with skills and experience plus benefits that include medical, dental, and vision coverage, and a retirement savings 401(k) plan. Salary $70,000 - $85,000 per year #J-18808-Ljbffr