Clinical Research Assistant

Virginia Tech•Roanoke, VA

14d•Hybrid

About The Position

Under general supervision of the Principal Investigator, assists with administrative activities associated with the conduct of research studies including industry sponsored, grant funded, or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. This position will be assigned to support minimal risk or non-interventional studies, unless assigned to serve in a support function for greater than minimal risk studies that also include a Clinical Research Coordinator or Clinical Research Nurse. The primary duties of the role will include, but may not be limited to, the following: Assist in overseeing compliance to research protocols. Assists with completion and submission of study related documentation. Assist in monitoring enrollment goals. Coordinates tasks related to research subjects such as assisting with development of informed consents and screening materials, scheduling visits, obtaining informed consent, and acting as a liaison between research participants and the research study team. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Collect research specimens as directed in the protocol. Ensure compliance with protocol guidelines and requirements of regulatory agencies. Tracks and reports adverse events and protocol deviations. Under supervision of Principal Investigator, coordinates all site related monitoring or auditing visits from sponsor and/or federal agency during the course of the study and at closure. Prepares, submits and maintains IRB, OSP, and/or any other funding or regulatory documents and research correspondence. Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, and enrollment logs. Candidate will be expected to complete IATA certification within 60 days of hire. Position requires local travel between Roanoke and New River Valley locations. Position requires pre-employment conviction, driving, and drug-panel screening.

Requirements

Previous research experience, preferably with human subjects.
Demonstrated organizational skills and acknowledgement of safety protocols.
Ability to maintain a high level of confidentiality and professionalism.
Open to working weekends and nights as necessary to meet business needs.
Demonstrated communication skills.
Ability to work independently and as part of a team.
Ability to manage multiple tasks and exceptional time-management skills.
Pre-employment conviction, driving, and drug-panel screening.
Criminal conviction check.

Nice To Haves

Coursework or training in biology, health sciences, biochemistry, exercise physiology, or another related field.
Experience with basic laboratory protocols, especially proper collection, handling, or processing of biospecimens.
Knowledge of medical and/or pharmaceutical terminology strongly desired.

Responsibilities

Oversee compliance to research protocols.
Complete and submit study related documentation.
Monitor enrollment goals.
Coordinate tasks related to research subjects such as assisting with development of informed consents and screening materials, scheduling visits, obtaining informed consent, and acting as a liaison between research participants and the research study team.
Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
Collect research specimens as directed in the protocol.
Ensure compliance with protocol guidelines and requirements of regulatory agencies.
Track and report adverse events and protocol deviations.
Coordinate all site related monitoring or auditing visits from sponsor and/or federal agency during the course of the study and at closure.
Prepare, submit and maintain IRB, OSP, and/or any other funding or regulatory documents and research correspondence.
Develop and maintain patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, and enrollment logs.
Complete IATA certification within 60 days of hire.