This is a fulltime position that requires a hardworking, energetic, experienced clinical research assistant available to assist in conducting pharmaceutical sponsored clinical trials from pre-study preparation through closeout visit in accordance with FDA regulations and GCP guidelines. The potential candidate must be Bilingual (English & Spanish) and possess working knowledge and understanding of clinical trial protocols, including requirements of patient eligibility, meeting enrollment goals, visit schedule, assessments and lab procedures, and drug accountability.
Skills Required:
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.
Job Type: Full-time
Pay: From $15.00 per hour
Expected hours: No more than 40 per week
Benefits:
Medical specialties:
Physical setting:
Schedule:
Ability to Relocate:
Work Location: In person
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