Clinical Research Coordinator II

Responsibilities

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

Preferred

Therapeutic area: neurology, psychiatric, or oncology clinical trial experience highly preferred

Full vital signs collection

Specimen processing

EKG performance and basic interpretation

Full informed consent administration

Concomitant medication collection

Medical and psychiatric history collection

Benefits

Medical coverage

Dental coverage

Vision coverage

Retirement savings 401(k) plan

Sunstone Therapies focuses on the research and commercial delivery of psychedelic therapies for cancer patients.

Rockville, Maryland, USA

https://www.sunstonetherapies.com/

Total Funding

$8.49M

2024-07-22

Series Unknown· $8.49M

Leadership Team

Kimberly Roddy

Co-Founder and COO of Sunstone Therapies, LLC

Ronald Mis

Co-Founder

Recent News

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Reunion Neuroscience Announces First Patient Dosed in REKINDLE Phase 2 Clinical Trial of RE104 for the Treatment of Adjustment Disorder (AjD) in Cancer and Other Medical Illnesses

2025-09-30

News-Medical.Net

Single-dose of psilocybin shows long-term relief for depression in cancer patients

2025-06-17

Psychedelic Science 2025

Psychedelic Science 2025 Expands Business Track, Announces Select Speakers and Featured Sessions

2025-05-08

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Qualifications

Education: RN (ADN or BSN) or Bachelor's degree (BS/BA) in any discipline

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

Therapeutic area: neurology, psychiatric, or oncology clinical trial experience highly preferred

Full vital signs collection

Specimen processing

EKG performance and basic interpretation

Full informed consent administration

Concomitant medication collection

Medical and psychiatric history collection

Required skills

Clinical Research Coordination, Human Subjects Research, Clinical Research Methodology, Phlebotomy, Clinical Practice (GCP), Neurology Clinical Trials, Psychiatric Clinical Trials, Oncology Clinical Trials, Vital Signs Collection, Specimen Processing, Performance and Interpretation, Informed Consent Administration

Preferred skills

Full vital signs collection, Specimen processing, EKG performance and basic interpretation, Full informed consent administration, Concomitant medication collection, Medical and psychiatric history collection

Experience

3+ years