• Must be able to self-train on protocols, protocol amendments, investigator brochures, and study-related manuals.
• Must be able to multitask between different protocols of variable therapeutic areas, including several enrolling protocols simultaneously.
• Work closely with the Investigators to review medical records, screen study participants, and perform all applicable protocol procedures.
• Assists Principal Investigator in conducting studies to ensure integrity of data and safety of subjects
• Manages studies with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
• Conducts, organizes and ensures compliance with clinical research trials according to protocol-stipulated regulations, SOPs, and GCP guidelines.
• Performs study-related procedures in compliance with protocols including but not limited to drug dispensation, compliance and drug accountability, vital signs, phlebotomy, ECG, questionnaires, and surveys.
• Attends IM, SIV, and any other training session required by the sponsor.
• Review study protocols and complete study training.
• Ensures they receive access, approvals, and study supplies, such as lab kits, study medication, diaries, questionnaires, rates training approval, and IRB approvals, including but not limited to ICF English/Spanish protocol approval, recruitment materials are on site prior to initiation.
• Consents subjects per GCP/Protocol guidelines.
• Develop their own source documents following the site’s template
• Keeps site system and imports up to date regarding subject status in a trial.
• Ensures proper follow-up of subjects
• Resolves any CRA queries and pending action items in a timely fashion and assists monitors during on-site or remote monitoring visits.
• Maintains PI/Sub-Is/Lead CRC always informed on all aspects of the trial by giving them copies of, but not limited to, all follow-up letters and sponsor/IRB relevant correspondence. Also, it brings lab alerts AE and SAE to their attention.
• Ensures all deviations, violations, AEs, and SAEs are captured, recorded, followed, and reported to sponsor/IRB in a timely manner,
• Meets or exceeds expected enrollment, retention, and screens failure goals.
• Screen, enroll subjects, and schedule subject visits in conjunction with the Principal Investigator
• Correspondence with sponsors, labs, IRB, and other regulatory organizations
• Maintain organized, accurate, and complete study records
• In conjunction with the Principal Investigator, accurately report and track adverse events as defined by each study protocol
• Perform study close-out procedures
• Must have excellent verbal and written communication skills in order to politely and effectively communicate with the site staff as well as the study team, sponsor vendors, etc.
• Must work in conjunction with our recruitment department to prescreen potential candidates for several research protocols at a time.
• Must work in conjunction with our Quality Assurance department to implement corrective and preventative actions in order to ensure subject safety, data integrity, as well as compliance with all applicable regulations and guidelines.

Skills and Qualifications

• Minimum of 2 years of clinical research experience is required.
• High School Diploma or its equivalent; College degree preferred.
• Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledgeable in medical terminology
• Excellent communication skills (interpersonal, written, verbal)
• Basic computer skills, including Word, and Excel, as well as proprietary applications unique to the clinical research industry
• Bilingual- English and Spanish required