Clinical Research Coordinator II - MDMA-AT

Responsibilities

• Reviews new patient records and screens participants for eligibility in research protocols.
• Interviews patients for study participation and collects appropriate data to support recruitment activities, including assessing patient commitment and obtaining informed consent.
• Educates patients about the research protocol, their role in the study, and all required procedures, risks, and expectations.
• Collections, organizes, catalogs, disseminates, and maintains accurate and complete research data and study files.
• Serves as a liaison between patients, study therapists, investigators, and physicians, acting as a key patient resource throughout the study.
• Enters, transcribes, and resolves data queries in case report forms (paper and/or electronic systems) in collaboration with study leadership.
• Ensures strict adherence to legal, professional, and ethical standards related to confidentiality, participant safety, and data integrity.
• Serves as a key member of the team in ensuring compliance, safety, and efficiency at all stages of the study lifecycle, including study startup, participant recruitment efforts, data and specimen collection, project tracking, and study operations.
• Schedules participant visits, study sessions, and follow-up appointments, coordinating closely with clinical and research staff.
• Aids in monitoring visits, audits, and inspections by sponsors, IRBs, and regulatory authorities.
• Supports regulatory activities, including maintenance of regulatory binders, protocol amendments, adverse event documentation, and IRB submissions, as assigned.
• Maintains participant safety, including documenting and reporting adverse events and protocol deviations in accordance with study and regulatory requirements.
• Coordinates with therapy teams and study leadership to ensure protocol-driven timing, data collection, and session requirements are met, particularly in support of MDMA-assisted therapy sessions.
• Aids in and/or manages elements of study project tracking and clinical operations including, but not limited to regulatory submissions, training logs, study personnel records, and additional as needed.

Qualifications

• Bachelor's Degree required.
• Minimum of 3-5 years experience required.
• Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
• Excellent interpersonal and computer skills.
• Ability to communicate effectively and to work with individuals of all levels.
• Clinical risk management experience.
• Quality assurance.
• Ability to multi-task effectively.