What are the responsibilities and job description for the Clinical Research Coordinator II position at Sunstone Therapies?
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.
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
Click here to learn more about this role: https://jobs.gusto.com/postings/sunstone-therapies-clinical-research-coordinator-ii-50860710-ea81-4529-a73b-7937aa3e595d