Under the supervision of the Assistant Director of Nursing for Clinical Services, the Clinical Research Assistant ensures that clinical trials and studies are run according to Unity Research Policy. The incumbent works with the ultimate goal of protecting patients participating in research studies. Clinical Research Assistants draw on their experience to promote good clinical practices and professional management of clinical studies.
Under the direction of the Assistant Director of Nursing for Clinical Services, the Clinical Research Assistant in his/her designated specialty is responsible for promotion of good clinical practices and medical care in the conduct of clinical investigation. This will be performed by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents. By the very nature of the profession, the level of assignment will call for a maximum degree of knowledge, professional judgment, and ingenuity.
MAJOR DUTIES/ESSENTIAL FUNCTIONS
A. ENSURES PROTOCOL COMPLIANCE:
· Possesses a thorough understanding of the requirements of each approved protocol in the research portfolio under his/her direction.
· Determines that inclusion/exclusion criteria are applicable to the study population.
· Implements any protocol deviation or changes only with PI's agreement.
· Reviews the inclusion/exclusion criteria, schedule of visits, end point criteria, and investigational article use with the research team.
B. SUPERVISES RESEARCH STAFF:
· This position does not require supervision of other staff.
C. MANAGES THE MEDICAL CARE OF SUBJECTS:
· Ensures qualified personnel (PI or sub-investigator) are informed of all trial-related medical decisions.
· Evaluates for adverse experiences.
· Ensures that medical care is provided to a subject for any adverse event(s) under the direction of the PI.
· Documents in the medical record the subject's participation in the trial.
D. PROTECTS THE RIGHTS AND WELFARE OF SUBJECTS:
· Reports all serious adverse events immediately to the PI.
· Obtains a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-related procedures.
E. ENSURES VALIDITY OF THE DATA REPORTED:
· Ensures the accuracy, completeness, legibility, and timeliness of case report forms and source documents.
· Ensures that case report forms accurately reflect source documents.
· Explains any discrepancies between source documents and case report forms.
· Endorses changes or corrections to a case report form.
· Communicates effectively with PI.
· Meets regularly with the PI and research associate(s) to discuss subject participation and protocol progress.
· Under the general direction of the PI, works to integrate research operations with the clinic site leadership team (Health Center Director, Medical Director, or designee).
· Participates in monitoring visits and audits as appropriate.
· Permits monitoring and auditing by the sponsor and appropriate regulatory authorities.
· If already available, maintaining current license to practice nursing, physician's assistant license, or nurse practitioner license.
· Bachelor's degree preferred.
· Ability to provide the PI with credentials as requested.
· Disclosing conflicts of interest as described in the regulations.
· Strong data management and computer skills.
· Experience working with research databases like Microsoft Excel.
· Excellent verbal and written communication skills.
· Ability to prioritize and work independently.
KNOWLEDGE & EXPERIENCE REQUIRED BY THE POSITION
· Knowledge of HIV and research by training, education, or experience.
· Ability to manage time effectively and organize own work.
· Effective communication skills, both verbal and written.
· An understanding of research processes and methodologies.
· Good level of computer literacy.
· Ability to record and check data to ensure accuracy.
· Willingness to seek help, advice, and support as required.
· Willingness to work as part of a research team.
· Willingness to undergo training as required by the position.
· Understanding of the need for confidentiality in dealing with information.
· Ability to communicate information to other people effectively.
· Ability to manage day to day work independently.
This position reports directly to the Assistant Director of Nursing for Clinical Services. The Clinical Research Assistant works in collaboration with clinical leadership.
This position abides by all rules and regulations set forth by applicable licensing and regulatory bodies, as well as UHC policies and procedures. Strict adherence to the IRB approved protocol and research standards are required.
This position has primary contact with the clients and employees of Unity Health Care, Inc. The position requires contact with staff at all levels throughout the organization. This position works with the PI, Research Coordinator, Director of Clinical Services, Protocol Team, Unity Site Leadership team, Unity Health Care patients, the study sponsors (e.g., George Washington University), the study data management team (e.g., Cerna Corporation), and others as appropriate.
Refer to attached ADA requirements for the position. Some walking, standing, bending, and carrying of light items such as books and paper is required.
Refer to attached ADA requirements for the position. The position works involves everyday risk and discomforts, which require normal safety precautions typical of such places as offices, meetings, training rooms, and other UHC sites. The work area is adequately lit, heated, and ventilated.
OTHER SIGNIFICANT FACTS
Hours may include some evenings and/or Saturday work. The incumbent must be able to balance the needs of diverse constituencies on a daily basis.
The position involves everyday risk and discomforts, which require normal safety precautions typical of such places as offices, meetings, training rooms, and other Unity Health Care Inc. Business Sites. The work area is adequately lit, heated, and ventilated. The position requires contact with staff at all levels throughout the organization. There are also external organization relationships that may be a part of the work of this individual.
The statements contained herein describe the scope of the responsibility and essential functions of this position, but should not be considered to be an all-inclusive listing of work requirements. Individuals may perform other duties as assigned including work in other areas to cover absences or relief to equalize peak work periods or otherwise balance the workload.