Grant Funded Clinical Research Assistant Oncology Research

Carilion Clinic•Roanoke, VA

1d•Onsite

About The Position

The Clinical Research Assistant assists with administrative activities associated with research studies including industry sponsored, grant funded. The Clinical Research Assistant 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. Supports 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. Assists in overseeing compliance to research protocols. Assists with completion and submission of study related documentation. Communicates with study team, research sponsor or CRO, local or central IRB, Office of Sponsored Projects, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance. Assists 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. Collects research specimens as directed in the protocol. Ensures compliance with protocol guidelines and requirements of regulatory agencies. Tracks and reports adverse events and protocol deviations. 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, FDA 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.

Requirements

Bachelor’s degree in science or a related field required. 4 years of clinical research experience may be considered in lieu of degree.
None.
IATA certification required.
Excellent computer skills, including strong knowledge of word processing, spreadsheets, databases, and internet applications.
Strong organizational and communication skills required.
Ability to manage multiple tasks and work effectively in an environment with frequent interruptions.

Responsibilities

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.
Supports 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.
Assists in overseeing compliance to research protocols.
Assists with completion and submission of study related documentation.
Communicates with study team, research sponsor or CRO, local or central IRB, Office of Sponsored Projects, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
Assists 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.
Collects research specimens as directed in the protocol.
Ensures compliance with protocol guidelines and requirements of regulatory agencies.
Tracks and reports adverse events and protocol deviations.
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, FDA 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.