NIDA RESEARCH COORDINATOR

Job Description
 

1. primary purpose for the position of Research Coordinator (RC) is to assist in the conduct of a research study by supervising the Research Assistant (RA) and to serve as a link to study staff and other parties involved with the execution of the research study. The RC, in conjunction with the site Principal Investigator (PI), will also ensure on a day-to-day basis that the study procedures are being followed. The RC will have a primary relationship with the participants and is critical to successful recruitment and retention of participants.

RESPONSIBILITIES & DUTIES

Depending on the size of the study, a RC may be required to fulfill the following responsibilities:

1. 1. Supervise Research Assistant (RA).
   2. Assures all study procedures are being followed on a day-to-day basis (e.g., that participants are scheduled in a timely fashion, reminded of study visits, followed-up if visits are missed, that all required data is collected during each visit, as well as Adverse Events and Serious Adverse Events are appropriately collected and/or reported).
   3. Performs basic study duties, including collecting data from face-to-face visits, as well as collecting data from telehealth visits, if applicable.
   4. Prior to study start up, assist in developing Standard Operating Procedures (SOP) that are a site-specific supplement to the Manual of Procedures (MOP) for the protocol.

1. 1. Reviews forms/records and data entry; cross check data entered by others.
   2. Assists RA with indirect service functions at any peak times; particularly important is coordinating study visits with clinical staff working with participants so that clinical staff can assist with retention and attendance at each study visit.
   3. Serves as main point of contact between Project Manager and local study staff.
   4. Oversees the checking process for case report forms (CRFs) and electronic case report forms (eCRFs) and their submission to the data center.
   5. Oversees responses to data queries and ensures they are resolved in a timely manner.
   6. Coordinates transportation needs of participants with Transportation Coordinator, when applicable.
   7. Acts as liaison with clinical staff to identify study participants and discuss study with potential participants.
   8. Assists with recruitment efforts in the initial phase of study and throughout, when applicable.

1. 1. Performs additional retention activities (calling participants who did not attend visits, calling their contacts, sending letters, etc.).
   2. Responds to questions or requests for information from the Lead Team, Data Coordinating Center, or Clinical Coordinating Center.
   3. Ensures adequate study supplies are available for study staff.
   4. Is responsible for maintaining all local regulatory documents.
   5. Ensures all research staff are utilizing the correct version of the informed consent(s), protocol, and other study documents.
   6. Ensures that study documents are in order prior to study monitor visits.
   7. Acts as liaison between monitor and study staff regarding any issues found.
   8. In conjunction with Site PI, facilitates local team meetings.
   9. Attends meetings, including teleconferences with the Lead Team and clinical staff/team meetings, when appropriate.
2. 1. Participates in training and continuing education as requested.
3. 1. Performs other duties as assigned.

SUPERVISED BY:

Site Principal Investigator

POSITIONS SUPERVISED:

Research Assistant

QUALIFICATIONS:

This position requires a Bachelor’s Degree in related science or an equivalent combination of education and experience. Must be detail/task oriented and possess proficient computer skills. Demonstrated ability in clinical research projects is required.