- Maintain a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, (ensuring adherence to International Conference on Harmonization (ICH) Guidelines (E6) for Good Clinical Practices (GCPs) as well as all other federal, state, and local guidelines), patient visit schedules, test procedures, laboratory information, and drug accountability requirements.
- Recruiting and screening of subjects for eligibility, including conducting informed consent process with subjects.
- Completing of all study documentation forms, including creation of source documents, case report forms (CRF) and other study specific documents. Ensure CRF data entry is complete within 24 hours, and queries are addressed appropriately within 48 hours, or as required, whichever is sooner.
- Coordinating and conducting patient care visits (drawing blood, collecting vital signs, performing ECGs, and processing specimens), including dispensing and recording subject stipends, and assuring all procedures are conducted in compliance with the clinical protocol.
- Close monitoring of, including ensuring abnormal or missed labs are redrawn as soon as possible; AEs/SAEs are reviewed and reported as required; and PI/Sub-I is made aware of any potential safety issues immediately.
- Interacting with Principal Investigator as needed to assure the patient receives appropriate medical evaluation and care when needed, and alerts the Principal Investigator of serious adverse events or other changes in health status.
- Receive, dispense, and account for related trial supplies.
- Maintaining study regulatory files including preparing and submission of subject-related documents (deviations, Serious Adverse Events, etc.) to the IRB.
- Interacting with and maintaining close communication with the sponsor's Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process.
- Reviews quality assurance chart audits and implements corrective action as necessary.
- Attending sponsor Investigator/Study Coordinator meetings as needed for assigned protocols.
- Adheres to all company SOPs and covenants.
- Maintain ICH/GCP training and any others as required to comply with ICH and all other federal, state, and local guidelines.
- All other job functions and duties as required or requested.
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Clinical Research Coordinator CRC - Orlando, United States - Omega Research
Description
Job Description
Job DescriptionHere we grow again Our busy clinical research sites in Debary and Orlando are looking for new study coordinators to join our team The ideal candidate will have experience working with phase 1, 2, and/or 3 clinical trials in various indications including ulcerative colitis, crohn's disease, kidney disease, liver disease, uterine fibroids, endometriosis, lupus, and rheumatoid arthritis. Being bilingual is a huge plus
Not a CRC or RN but still interested in research? Do you possess strong attention to detail and want to work in a field where you not only make a difference on a daily basis but will let you get into a career where the sky is truly the only limit? Feel free to reach out, we are open to training the right candidate :)
All staff enjoy competitive wages, PTO, medical, dental, vision benefits plus 401k with a 6% match
Summary of Position:
Coordinate clinical studies from pre-study planning through successful completion of all patient visits and documentation. Performs all activities related to the coordination of a clinical study while providing exemplary customer service in order to ensure effective and efficient operations.
Key Responsibilities:
Qualifications:
Registered Nurse with exceptional organizational skills, attention to detail and demonstrated human relations and effective communication skills required; Excellent verbal and written communication skills; Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers; Strong problem-solving skills; Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads; Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic; Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other sensitive information; prior clinical research experience or a scientific and medical background is a plus.
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