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Clinical Research Coordinator

4 months ago


Fort Lauderdale, United States Trinity Health Full time

Employment Type:Full timeShift:Day ShiftDescription:Job Summary:conduct and oversee all aspects of clinical trials in the neuroscience Insititute. This person will be responsible for the conduct of multiple clinical research activities. Ideal candidate will have industry sponsored clinical trial experience and/or project management experience for investigator initiated projects. Person is able to work with minimal supervision and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits. Person will be responsible for leading and managing the project from the standpoint of clinical research activities. Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulations. Must adhere to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. Experience with clinical trials and industry sponsored studies preferred.Job Requirements:Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.Plan and coordinate strategies for patient enrollment, increasing patient enrollment, an improving efficiency.Review the progress of department research studies to ensure adherence to research protocols and take action to correct problems such as deviation from protocol requirements.Coordinate with other departments when necessary to ensure study-related procedures are performed according to the protocol.Coordinate and facilitates study-related meetings such as pre-study visits, site initiation visits, monitoring visits.Prepare for or participate in quality assurance audits conducted by internal staff, study sponsors, federal agencies, or specially designated review groups.Maintains own study participant caseload.Periodically reviews study participant research charts and assesses the quality of work for each CRA/CRA-RN.Coaches CRAs/ CRA-RNs in areas that need improvement.Periodically observe specimen collection, processing, shipping and storage activities to ensure they are conducted appropriately.Periodically observe the investigational drug ordering, deliver, administration, return and accountability activities to ensure they are carried out appropriately.Keep research management informed in a timely manner of actual or potential deficiencies in quality or performance of CRAs/ CRA-RNs.Assists research management in developing systems for assuring protocol adherence and data quality.Assist in the annual evaluations of research associates as applicable.Acts as an internal and external research leader at Holy Cross Hospital, advising staff regarding complex protocols and projects.Encourages teamwork and cohesion within the research work unit, and between research and other departments in the organization.Coordinate delegated activities during the contract and budgeting process.Oversee the training and development of new associates.Education:Bachelor's degree with a minimum of 4 years of experience in clinical research required, or Master's level degree with a minimum of 3 years of experience in clinical research required.Current certifications with ACRP (CCRC) or SOCRA (CCRP) as a clinical research coordinator required.Experience & Skills:Minimum two (2) years of clinical trial research experience preferredNeeds to demonstrate consistent professional conduct and meticulous attention to detailMust possess excellent verbal and written communication skills and excellent interpersonal skillsAbility to work independentlyMust be computer literate; proficiency in Microsoft Word and Excel a must.Able to effectively present information and respond to questions from physicians, staff and patients.Good organizational skills.Able to function effectively in a team settingDriving may be required on some occasionsLicensure/Certification:SOCRA/ACRP Certification preferred (required to sit for CCRP/CCRC after 2 years' experience)Current BLS Certification requiredOur Commitment to Diversity and InclusionTrinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.