Clinical Research Coordinator
- Posted: over a month ago
- Benefits: 401k, dental, life insurance, medical, vision,
The Clinical Research Coordinator coordinates the initiation, implementation, and continued progress and close-out visits of clinical trials as well as monitoring visits with Investigators, laboratories, sponsors, clinical staff or other individuals and organizations as needed.
Key Tasks and Responsibilities
- Responsible for the coordinator of care and study subject activities during and in preparation of study course, including but not limited to phone calls and other forms of communication with study subjects, coordination of procedures schedule and office visits, in collaboration with office staff as needed.
- Masters protocol information and makes it available during decision-making meetings and other opportunities.
- Responsible for research data capture.
- Schedule management as they relate to the research project.
- Responsible for the identification, in conjunction with other clinical staff as needed, of required study resources prior to study implementation.
- Assists investigators with study subject recruitment and eligibility, patient visits, questionnaires and diaries as required per study protocol.
- Responsible for handing physicians and study subjects the most current version of study specific informed consent forms, in a language that the potential study subject understands.
- Administers or designates a responsible party to administer study drugs, collecting or designating a responsible part to collect biological materials from study subjects, and then processes and ships specimens as required.
- Assesses vital signs and pediatric/adult phlebotomy as needed.
- Collects, processes, stores and ships biological samples as needed.
- Maintains all aspects of the study including recruiting, screening, enrolling, and follow-up care to meet protocol requirements.
- Maintains accurate and complete written source documentation of patient visits, and protocol related activities, including documentation of patient assessments, observations, test results and other study related information per federal regulations/ICH guidelines, GCPs, CTT SOPS, sponsor/CRO and IRB requirements.
- Completes accurate electronic or manual CRFs/eCRFs/queries and or worksheets generated by the sponsor/CRO/investigator.
- Maintains accountability for clinical trial materials (i.e. CRFs, study drug, lab supplies, and/or other required items) and ensures availability of appropriate amounts for the conduct of the study.
- Promptly reports adverse events to Principal Investigator/Sub-Investigator, sponsor/CRO as deemed necessary and to ensure subject safety.
- Performs all study-related duties in a time- and cost-effective manner in adherence with CFPG policies.
- Other duties as assigned.
Education and Experience
- Degree in nursing, respiratory therapy or comparable health-related field preferred
- At least two years previous experience as a Clinical Research Coordinator
- Expert knowledge of GCP and Clinical Trials Conduct
- Must demonstrate abilities in clinical research operations.
- Excellent communication skills, both written and verbal & interpersonal skills a must
- Detail oriented with exceptional organizational skills
- Strong sense of responsibility and initiative
- Above average computer skills
- Ability to multitask and work with continual interruption
- Team player attitude with willingness to make active contributions
- Comprehensive medical coverage
- Dental and vision
- Life insurance
- Short and Long term disability insurance
- 401(k) with profit sharing
- Paid time off and paid holidays
Central Florida Pulmonary Group, PA
Central Florida Pulmonary Group is dedicated to the health of our patients and the Central Florida community by delivering the highest quality of care for patients with pulmonary diseases, critical care illness and sleep disorders. Our Physicians are board certified in Internal Medicine, Pulmonary Disease, Critical Care Medicine, and Sleep Medicine. We are affiliated with the finest hospitals throughout Central Florida, and we are on call 24-hours a day to handle emergencies.
1115 E Ridgewood StOrlando, FL
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