Clinical Research Assistant
Employment Type: Full-time
GENERAL SUMMARY OF POSITION: Under the direction of the primary study coordinator and/or supervisor, assists with the implementation of clinical research activities ensuring adherence to protocol requirements, in accordance with federal research regulations.
The primary function of this position is to carry out screening, recruitment, and consenting of research protocol participants on nontreatment protocols.
Duties will include obtaining, collecting, processing, and shipment of human biological specimens and research data.
In addition to research activities, the research assistant will be responsible for activities including clerical support, file maintenance, daily courier rounds, and maintaining/ordering office and specimen collection supplies.
PRINCIPAL ROLES AND RESPONSIBILITIES: This is a brief description of the essential roles, responsibilities, and activities which are typically performed by this position.
- Assists the research team in assigned research study activities according to ability such as activities related to start-up, pre screening, recruitment, eligibility, screening, study visits, and study termination.
- Maintains protocol-related supplies and equipment and maintains and supplies office equipment as required.
- Maintains investigational items temperature logs as required.
- Assists the research team in coordinating and obtaining biological specimen collections.
- Processes, ships, and logs protocol required biological specimens, and monitoring for delivery while maintaining compliance with the protocol and federal regulations.
- Collects protocol, and CRF required participant data including abstraction from medical records and other source data as requested.
- With assistance, submits protocol required imaging to study sponsors.
- Maintains study-specific correspondence, source documents, and other study-required documents.
- Enters study data into the data system such as the Case Report Form per protocol requirements.
- Maintain participant records and file system; make copies as required, de-identify charts as required.
- Provide clerical support including copying, filing, faxing, phone messaging, and paging.
- Prepares the subject’s chart for a study visit. Preassembles blank participant charts.
- Obtain physician/investigator signatures on documents as assigned.
- Perform assigned work safely, adhering to established departmental safety rules and practices; report to the supervisor, in a timely manner, any unsafe activities, conditions, hazards, or safety violations that may cause injury to oneself, other employees, protocol participants, and visitors.
- Perform other related duties as required.
EDUCATION AND/OR TRAINING: High School graduate with one (1) year of clerical or secretarial experience required. Medical assistant and phlebotomy experience preferred. An equivalent combination of education and experience may be substituted.
LICENSURE/ CERTIFICATION/ REGISTRATION: None, minimum experience and preferred knowledge, abilities, and skills
Computer skills are necessary to accomplish the principal duties and responsibilities listed above, using the existing hardware, software, and peripherals available within the department including the processing of documents and spreadsheets.
Ability to be trained in the operation of special equipment as required by the protocol.
Ability to prioritize, plan and organize work; communicate verbally and in writing; proofread or edit material; perform arithmetical and simple calculations; and maintain the confidentiality of information.
Ability to function independently and as a team member. Ability to be self-motivated.
Ability to coordinate simultaneous procedures with accuracy. Skill in oral and written communication.