Clinical Research Assistant-New Jersey Ave. DC-Part Time

Unity Health Care.•Washington, DC

2d•Onsite

About The Position

Unity Health Care is seeking a detail-oriented and highly organized Clinical Research Assistant to support the successful conduct of clinical trials and research studies in accordance with Unity Health Care policies, approved research protocols, and applicable federal and state regulations. Under the supervision of the Clinical Research Coordinator/Research Physician, the Clinical Research Assistant supports good clinical practices, protects the rights and welfare of research participants, ensures protocol compliance, and helps maintain the accuracy and integrity of research data. The ideal candidate will have an understanding of research processes, strong organizational and data management skills, excellent communication abilities, and the ability to work independently while collaborating effectively with a multidisciplinary research team.

Requirements

High school diploma required.
Knowledge of HIV and clinical research through education, training, or professional experience.
Understanding of clinical research processes and methodologies.
Strong attention to detail and demonstrated ability to maintain accurate records and data.
Strong organizational and time-management skills.
Ability to prioritize tasks and work independently.
Strong verbal and written communication skills.
Ability to work effectively as part of a multidisciplinary research team.
Demonstrated ability to communicate and work effectively with diverse populations.
Strong data management skills and proficiency with Microsoft Office Suite, including Microsoft Excel.
Ability to maintain confidentiality and handle sensitive information appropriately.
Willingness to complete required training and seek guidance and support when needed.

Nice To Haves

Bachelor's degree preferred.
Current nursing or physician assistant license preferred.

Responsibilities

Ensure clinical trials and research studies are conducted in accordance with approved protocols, Unity policies, and applicable regulatory requirements.
Develop and maintain a thorough understanding of assigned research protocols, including inclusion and exclusion criteria, visit schedules, endpoints, and investigational products.
Review protocol requirements with research team members and support adherence to approved study procedures.
Ensure protocol deviations or changes are implemented only with appropriate Principal Investigator (PI) approval.
Support the medical care and safety of research participants under the direction of the PI and qualified clinical personnel.
Identify and evaluate adverse events and ensure appropriate medical follow-up and documentation.
Promptly report serious adverse events to the PI.
Obtain appropriate signed and dated informed consent before study-related procedures are initiated.
Document research participation and relevant study information accurately in the medical record.
Ensure case report forms and source documents are accurate, complete, legible, and submitted in a timely manner.
Verify that case report forms accurately reflect source documentation and appropriately address discrepancies or corrections.
Maintain effective communication with the PI, Clinical Research Coordinator, research associates, and clinic leadership regarding participant participation and study progress.
Participate in regular research team meetings to discuss study progress and participant status.
Support the integration of research activities with clinic operations and leadership.
Participate in sponsor monitoring visits, audits, and regulatory reviews as appropriate.
Maintain confidentiality of participant and research information.
Maintain accurate research records and databases.
Follow all applicable research, regulatory, licensing, and Unity Health Care requirements.
Perform other related duties as assigned.