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Clinical Coordinator

clinical coordinator

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Recharge Rates

ACTRI staff have the expertise to guide Principal Investigators from site selection through regulatory approval, subject recruitment to study completion.

Clinical coordinators are available on a recharge basis. Other ways they can help with clinical research include communications with sponsors, scheduling subject visits, and database management. In addition, the coordinators can measure vital signs, perform ECGs, conduct subject evaluations, and process and ship samples.

Coordinator services are provided on an hourly basis or can be assigned at a percent effort to an individual investigator for a specified period of time. Coordinators are available to assist on a study for a maximum of 50 percent time.

Determining the Staff Needed

The staffing needed for a clinical research project is determined by the kind of study being conducted. Although the project's budget must be kept in mind, adequate staffing is critical to the safety and success of the study. The following should be considered when determining staffing needs for a new project:

Assistance with Clinical Coordination

A Clinical Coordinator can assist in screening study participants, ensuring continuity in data collection, maintaining data, or in carrying out other tasks, as described below.

Typical Duties of a Clinical Coordinator

While the principal investigator is ultimately responsible for the conduct of a study, including the safety and welfare of any clinical research participants, tasks such as the following are commonly delegated to a research coordinator:

  • Overseeing screening and enrollment
  • Conducting the informed consent process
  • Documenting eligibility of study participants
  • Conducting study visits
  • Obtaining and shipping specimens
  • Completing case report forms
  • Preparing adverse event forms
  • Developing quality assurance and quality control measures
  • Communicating with the study sponsor

Assistance with Regulatory Tasks

Staff members may be specifically hired to handle regulatory work and clinical coordination. It can be demanding to ensure that a project complies with Institutional Review Board (IRB) regulations throughout the study period, and that IRB submissions are handled properly and on time. Submissions involving more than two consents may incur additional fees. Services the ACTRI can provide include:

  • Handling IRB submissions and correspondence
  • Preparing consent forms and the research plan to be followed in accordance with protocol
  • Maintaining all regulatory documents
  • Communicating with the study sponsor