Clinical Research Assistant

This part time- position requires hard working, energetic, experienced research professional available to conduct pharmaceutical sponsored clinical trials from pre-study preparation through closeout visit in accordance with FDA regulations and GCP guidelines.

Possess working knowledge and understanding of all assigned protocols, including requirements of patient eligibility, meeting enrollment goals, visit schedule, assessments and lab procedures, drug accountability, and maintenance of regulatory documents. Assist in facilitating monitor visits and database clean up/lock with sponsor assigned CRAs.

Experience preparing sources, reviewing and conducting Informed Consent process with subjects, EDC entry and query resolution, and completing all study specific documents within the specified timeline. Review, file, and respond to all study specific documents, correspondence, and requests.

Other responsibilities include screening volunteers for eligibility in currently enrolling studies, patient recruitment, scheduling patient visits according to protocol schedule, reporting protocol deviations and gathering information on AEs and SAEs and reporting to physician, chief staff, supervisor, IRB, CRO, and Sponsors as required per protocol.

Must be able to work independently and efficiently in an extremely fast-paced work environment; multi-task and organize oneself; be highly detail-oriented, personable, outgoing, and work well with office team members; maintain open communication with physicians and chief staff in the conduct of trials, maintain professional conduct and communication with all staff, monitors, CROs and Sponsors; and attend (travel required) Investigator Meetings as needed.

Needs to have knowledge of medical terminology and medications, strong oral and written communication skills, knowledge of Microsoft Office and other computer applications as needed to fulfill job requirements. Needs to also have medical assistant skills like collecting vitals, performing EKG. Phlebotomy experience is a plus.

Spanish is required.

Job Type: Part Time

Experience:

• Clinical trials: 1 year (Preferred)
• Research: 1 year (Preferred)

Language:

• Spanish is required. (Required)

Job Type: Part-time

Pay: $14.00 - $18.00 per hour

Expected hours: 20 – 30 per week

Schedule:

• Day shift
• Monday to Friday

Work Location: In person