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26 days old

Clinical Research Coordinator III

University of Florida
Orange, Florida

The OneFlorida Clinical Research Consortium is seeking a qualified and enthusiastic individual to fill the Clinical Research Coordinator III position in the Orlando area. This position will work with the OneFlorida Study Development Program, under the direction of the Clinical Research Manager to coordinate and conduct observational and clinical trial research studies and manage all regulatory aspects of those studies. The responsibilities will include the day-to-day management and supervision of the Program research including but not limited to project implementation, training, clinic and participant recruitment, and regulatory compliance, This position requires knowledge of current clinical research best practices, experience in regulatory compliance, practice facilitation, and recruitment activities. The ideal candidate would possess superb interpersonal skills and have experience with clinician and community outreach and patient recruitment for clinical trials. Strong communication skills and the ability to work independently are a must.

Research Coordination

Participate in the informed consent process of study subjects. Support the safety of clinical research patient/research participants. Coordinate protocol related research procedures, study visits, and follow-up care. Screen, recruit and enroll patient/research participants. Report adverse events. Understand good clinical practice (GCP) and regulatory compliance. Complete and maintain Clinical Trial training and certification as needed Educate subjects and family on protocol, study intervention, study drug, etc. Schedule subject visits and procedures. Retain records/archive documents after study closure. Collect, process and send bio-specimen samples per study requirements
Screen, recruit, enroll and follow patients through IRB approved protocols. Maintain coordinator role responsibilities.
Clinician Outreach and Engagement
In collaboration with the CTSI, OneFlorida and Study teams and partners, conducts outreach and engagement among the OneFlorida partners and local clinicians
Identifies areas of interest and potential barriers for study participation in general and for particular studies
Project Administration

Responsible for day-to-day protocol management of all studies in the Orlando area, which includes patient assessment, management and data collection, scheduling study required procedures with other departments under the direction of the Principal Investigator. Assist the OneFlorida clinical research manager to develop recruitment materials, engagement strategies, monitoring processes and improvement activities. Function as an administrator of the Study Development Program in the Orlando area, with primary responsibilities for research staff supervision and development and project management. Develop and maintain study source documents. Coordinate research/project team meetings. Develop policies and procedures for standardized training and educational programs for both new hires and retraining for current staff in order to maintain clinical competencies, and knowledge of all regulatory requirements for research. Oversee staff in clinic and the community regarding participant recruitment Manage the contract deliverable calendar and corresponding deadlines for team members based on the contract deliverable schedule. Summarize work assignments, and manages office activities. Coordinate and staff research days at clinic
Assist study sites as needed, including travel and training if needed. Provide oversight of monthly reports detailing work allocation plans for team members. Disseminate important information about timelines and deliverables to team members and coordinates monthly reports to be delivered to external entities. Assist in planning all travel details and associated reporting for contract activities. Ensure that all team members are current with necessary trainings and keeps record of corresponding documentation. Manage inventory, mail, equipment, and overall work areas.


Supervision and Training

Oversee and train all new research coordinators and research assistants on current OneFlorida process and study protocols With the assistance of the clinical research manager, develop a training tracking system for research coordinators and research assistants Oversee day-to-day activities of research coordinators and research assistants. Create staff assignments and report staff progress on a weekly basis to the clinical research manager Oversee clinic staff as needed. Attend/conduct weekly meetings with staff to discuss barriers and issues on completing the project.


Acts as liaison for All of Us and the OneFlorida Clinical Research Consortium with partner, investigator, sponsor, and internal/external stakeholders. This includes but is not limited to conference exposition, presentations, and meetings as requested.


Perform other duties as assigned.

 

Expected Salary:

$55,000 - $65,000

 

Minimum Requirements:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

 

Preferred Qualifications:

Candidates should have excellent oral and written communication skills, be energetic, personable, and detail-oriented. Candidates should also have the ability to operate with considerable independence and initiative, to deal in confidence with sensitive information, and to multi-task and manage multiple competing priorities. Candidates should also demonstrate enthusiasm for intellectual rigor and engagement; excellent organizational and planning skills and excellent interpersonal skills. Candidates should be creative problem solvers. The successful candidate will be a persuasive communicator, an excellent network builder and an experienced project manager, who will be driven to deliver their recruitment targets. Preference will be given to candidates with prior experience managing large-scale clinical trials or interventions for a research study. Management experience preferred with knowledge of research methods, policies, procedures, and regulatory requirements of FDA, OPRR, and GCP. Phlebotomy experience preferred.

 

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

This is a time-limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

 

Categories

Posted: 2019-03-27 Expires: 2019-04-26

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Clinical Research Coordinator III

University of Florida
Orange, Florida

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