Clinical Research Monitoring (CRA)

Title: Part time Clinical Research assistant

Job Summary
The Research Assistant I provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies.

Essential Responsibilities and Duties

Creating and maintaining patient charts for all assigned studies.

Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts.

Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials.

Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication.

Assisting Coordinators in assessments, blood pressure, urine collection, blood draw labs.

Communicating with study participants, caregivers, third party vendors and laboratories as needed.

Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks.

Aiding Coordinators in the facilitation of study monitoring visits.

Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants.

Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Office/administrative tasks assigned e.g., resupplying exam rooms, ordering office supplies, answering phone calls, etc.

Education/Experience/Skills

High school graduate or equivalent. Bac

Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.).

Skilled in organization and record maintenance.

Strong personal initiative and attention to detail.

Ability to clearly communicate both orally and verbally.

Prior experience in healthcare, research, or clinical settings is a plus.

Basic knowledge of clinical research processes and regulations (GCP, FDA, IRB) is a plus.

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