Research Assistant I

Shift: Day

Working Hours:

Location: BH Center for Clinical Research

• Works with PI and staff to provide optimal patient care, safeguard patient confidentiality, and insure completeness and accuracy of necessary clinical information.

• Provides investigator with a flow sheet of the study synopsis with inclusion-exclusion criteria for each study.

• Demonstrates knowledge of each protocol with ability to determine if protocol requirements are being met; including aspects relating to timing of visit, procedures to be performed, and questionnaires and other documentation completed per protocol.

• Prepares/assesses patient charts/source documents for potential drug study candidates. Includes assisting in preparation of educational material for patient enrollment (advertising and brochures).

• Prepares/assesses chart for patient screening & study evaluations at each visit.. Ensures source documentation is accurate & complete prior to each visit (including dictation, lab results, reports for other tests/procedures as needed, forms for PI to complete).

• Assists front office staff in scheduling of patient visits and further exams/procedures as necessary. Responsible for correct study-specific visit title & detailed instructions given prior to next appointment date.

• CRA assists PI at each visit (scheduled and unscheduled). CRA interviews/ assesses patient for medication intake/compliance, adverse events and inter-current illnesses and administers questionnaires, tests, and surveys as outlined by study protocol.

• CRA assists lab in collection, processing, storage and transport of specimens in accordance with study protocol specifications.

CRA is responsible for any follow-up regarding abnormal laboratory tests as directed by physician, including contacting patient and repeat testing if necessary. Acts as liaison between patients, investigator, and study monitors.

• Maintains continuous communication with patients/participants to assess safety and compliance to study protocol.

• Maintains patient tracking information and submits to Sponsor as required.

• Reports Serious Adverse Events to Sponsor, PI, & Research Director within 24 hour period.

• Responsible for maintaining accurate and complete Case Report Forms for each patient, auditing for missing and questionable data.

• Responsible for ensuring that information for unscheduled visits, laboratory, and any other procedure not planned in the study are provided to budget director for charge entry.

• Provides PI and Research Director with weekly, updated study status report including: CRF status, significant adverse events, and status/quality of CRA's work/visit sched.
  

Other information:

• High School Diploma and/or GED
• Minimum 2 year medical field experience.

This job will be authorized 80.00 hours bi-weekly.