Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Location: Onsite 5 days/week in Rockville, MD

Hours: 10:30 am - 6:30pm

Reports To: Clinical Research Manager

Supervises: n/a

Duration: on-going

Context: Sunstone Therapies is the leader in the delivery of psychedelic-assisted therapy in the medical setting, focusing on the development and implementation of clinical trials today, and moving towards clinical delivery if and when therapies are approved. Right now, we have two sites with roughly 30 employees (not including trainee therapists) and are looking to build our team and expand to 2 more sites in the next 2 years. At Sunstone, our culture centers on love and rigor, prioritizing whole-person healing for all.

To be successful in this role in this growth stage start-up, the candidate must be a detail-oriented self-starter and problem solver. They should be able to quickly shift projects and priorities to meet emerging needs, collaborate across departments, and align their approach with Suntone’s values. Join us in making a profound impact in the realm of therapeutic research!

Scope: 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 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 CRC will collaborate closely with the regulatory affairs specialist, data manager, MAs, therapists, raters, and all other clinical research staff.

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.

A successful candidate must demonstrate the following skills, experience and competencies:

• Education: HS diploma or higher
• Experience: Minimum of 3 years of clinical research coordination experience, minimum of 1 year of sponsor-based research experience
• Strong understanding of clinical research methodology, regulatory requirements, and ethical principles governing human subjects research.
• Strong phlebotomy skills, and a willingness to learn how to process specimens
• Willingness to learn how to take  EKGs
• 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.

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.