Clinical Research Assistant

Description:

The Clinical Research Assistant (CRA) assists in the daily activities of clinical research studies and clinic operations. This role involves working closely with clinical teams, investigators, and study participants to ensure that all required procedures and visits occur according to protocol-specific guidelines.

Key Responsibilities:

Study Familiarization:

Thoroughly understand assigned studies by reading protocols, attending start-up meetings, and coordinating with the Principal Investigator and study team.

Protocol Adherence:

Ensure strict adherence to study protocols and obtain exemptions when applicable.

Specimen Collection & Processing:

Collect, process, and ship laboratory samples in accordance with study requirements.

Patient Screening & Qualification:

Collect initial psychiatric and medical information through patient interviews and access appropriate sources to qualify and accurately place patients in enrolling clinical trials.

Study Coordination Support:

Assist Clinical Research Coordinators in trial-related organization and documentation, including filing and maintaining regulatory records.

Communication & Reporting:

Communicate protocol issues to the study team, Site Administrator, Principal Investigator (PI), or Sub-Investigator as needed.

Clinical Tasks:

Perform clinical tasks such as vital signs measurement, height and weight recording, ECG administration, phlebotomy, and specimen packaging.

Documentation & Compliance:

Maintain timely source documentation and ensure compliance with sponsor-required information.

Patient Education:

Educate patients and their families about study participation and clinical drug trials in general.

Community Engagement:

Assist in community outreach events and provide appropriate community resource referrals to patients, caretakers, and family members when applicable.

Additional Duties:

Perform ad-hoc tasks and assist in other study-related activities as needed.

Additional Responsibilities:

This job description outlines the primary responsibilities of the Clinical Research Assistant; however, additional duties may be assigned as needed to support the research program or the operational needs of the organization. These additional responsibilities are not limited to the above and may evolve over time based on study requirements or business needs.

Requirements:

Knowledge, Skills, and Abilities:

Communication:

Ability to communicate effectively (both written and oral) with patients, study teams, and external stakeholders.

Interpersonal Skills:

Excellent interpersonal and customer service skills to engage with study participants and colleagues.

Organizational Skills:

Strong ability to prioritize tasks, manage multiple responsibilities, and maintain documentation.

Technical Proficiency:

Proficiency in Microsoft Office software required; knowledge of Electronic Medical Records (EMR) systems preferred. Attention to

Detail:

High level of accuracy in maintaining documentation and following protocol guidelines.

Team Collaboration:

Ability to work independently and collaboratively within a multidisciplinary team.

Confidentiality:

Ability to handle sensitive participant data while adhering to ethical and regulatory guidelines.

Required Experience and Qualifications:

Education:

Bachelor's degree preferred.

Experience:

Previous experience in a healthcare or clinical research setting is a plus.

Clinical Trials Knowledge:

Previous exposure to clinical trials is preferred but not required. This role is ideal for someone detail-oriented, organized, and eager to support clinical research in advancing medical knowledge and patient care.