2 Clinical Research Coordinator Jobs in Pembroke, FL
SRA Trials, LLC is Hiring a Clinical Research Coordinator Near Pembroke, FL
- Work closely with the Investigators to review medical records and screen study participants, as well as 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 of clinical research trials according to protocol stipulated regulations, SOPs, 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.
- Reviews study protocols and complete study trainings.
- Ensures they receive access, approvals, and study supplies i.e., lab kits, study medication, diaries, questionnaires, rates training approval, 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.
- Develops their own source documents following site’s template.
- Keeps site system and imports up to date regarding subject status in trial.
- Ensures proper follow up of subjects.
- Resolves any CRA queries and pending action items in a timely fashion and assists monitors during the onsite visits or remote monitoring visit.
- 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, sponsor/IRB relevant correspondence, brings lab alerts AE, SAE to their attention.
- Ensures all deviations, violations, AEs, SAEs are captured, recorded, followed, and reported to sponsor/IRB in a timely manner.
- Meets or exceeds expected enrollment, retention, screens failure goals.
- Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator.
- Correspondence with sponsor, labs, IRB other regulatory organizations.
- Maintain organized, accurate and complete study records.
- In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
- Perform study close-out procedures.
- 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 to ensure subject safety, data integrity, as well as compliance with all applicable regulations and guidelines.
- Minimum of 4 years of clinical research experience is required.
- High School Diploma or its equivalent required; College degree preferred.
- Must have understanding of regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
- Knowledgeable in medical terminology.
- Good computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry.
- Able to self-train on protocols, protocol amendments, investigator brochures and study related manuals.
- Able to multitask between different protocols of variable therapeutic areas, including several enrolling protocols at the same time.
- Must have excellent verbal and written communication skills (English and Spanish) to communicate with the site staff as well as the study team, sponsor vendors, etc. politely and effectively.
Job Summary
Full Time
$66k-90k (estimate)
03/12/2024
06/08/2024
The job skills required for Clinical Research Coordinator include Clinical Research, Written Communication, Accountability, Phlebotomy, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Coordinator. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Coordinator. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Coordinator positions, which can be used as a reference in future career path planning. As a Clinical Research Coordinator, it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Coordinator. You can explore the career advancement for a Clinical Research Coordinator below and select your interested title to get hiring information.
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