Clinical Research Coordinator

Company Description

Community Resource Initiative leads the fight against HIV and other infectious diseases, providing access and support through drug assistance, insurance support, prevention, and research. As a unique public health nonprofit in Massachusetts, our goal is to make the state a healthier place for all residents. We offer a holistic, client-centered approach with a focus on social justice and healthcare equity. Our contributions to clinical research have been instrumental in the FDA approval of almost all currently available HIV medications.

Role Description

This is a part-time, hybrid role for a Clinical Research Coordinator based in Boston, MA. The role would be 3 days on-site, one day remote. The primary responsibility of an experienced Clinical Research Coordinator (CRC) is to lead the day-to-day operations of CRI’s clinical research studies in a professional and confidential manner, ensuring accurate and timely execution of protocols by overseeing patient recruitment, data collection, study compliance and regulatory framework and requirements while working closely with the Principal Investigator (PI) to achieve study objectives. The CRC is responsible for maintaining high standards of quality and ethics throughout the research process. This role requires a candidate experienced in phlebotomy (mandatory) and other basic patient care procedures (blood pressure, EKG) ensuring the safe and efficient execution of clinical trials.

Successful applicants must have sufficient management skills to organize, supervise and carry out all aspects of clinical trials as well as the ability to work independently. They will have in-depth knowledge of protocol requirements and quality clinical practices as set forth by federal regulations. As the primary resource for protocols, the CRC is the liaison between Principal Investigator, Primary Care Providers, the Institutional Review Board, and Study Sponsors. With the Principal Investigator, the CRC will screen, enroll, and follow participants, ensuring protocol compliance and monitoring. They will also be responsible for all data and source documentation, adverse event reporting, and maintenance of regulatory files.

The individual in this position is an integral part of the small but strong research team. The candidate should possess the experience and passion to understand and communicate the clinical research process and a strong interest in learning about cutting-edge therapies in development for treating people with HIV/AIDS. S/he must be able to work as part of a dynamic team, get along well with a variety of individuals and groups, possess a positive outlook, and demonstrate the ability to be flexible in situations.

QUALIFICATIONS:

EDUCATION: College degree can be substituted by 4 years of relevant research experience.

EXPERIENCE: At least 5 years of experience as a Clinical Research Coordinator in a clinical setting.

ACCOUNTABILITY: This position reports to the Study Investigator for all clinical issues and the Executive Director for all administrative issues.

KEY RESPONSIBILITIES:

• Study Start-up and Recruitment: Screening potential participants, obtaining informed consent, and developing recruitment strategies to meet enrollment goals.
• Protocol Adherence: Ensuring all study procedures are conducted according to the established protocol, including data collection, monitoring adverse events, and timely reporting to the PI and sponsor.
• Data Management: Accurately collecting, recording, and maintaining patient data in electronic case report forms (CRFs) and other study documentation.
• Clinical Trial Management System (CTMS): Proficiency in using electronic platforms to manage study communication, data, track participant progress, and generate reports.
• Laboratory Coordination: Coordinating with laboratory personnel to collect and process study samples, ensuring the vitally important laboratory requirements and proper specimen handling and analysis.
• Regulatory Compliance: Adhering to all applicable regulatory guidelines (e.g., GCP, IRB) and ensuring study compliance with local and international standards.
• Team Leadership and Training: Providing guidance, training, and mentorship to junior CRCs on study protocols and procedures.
• Communication and Collaboration: Maintaining open communication with PI, Sponsor and other healthcare professionals involved.
• Adverse Event Monitoring: Promptly identifying, reporting, and managing any adverse events experienced by study participants.
• Study Closure Activities: Assisting with final data analysis, report generation, and archiving of study documents upon completion.