Find & Apply For Clinical Research Coordinator Jobs in Fleming Island, Florida

Northeast Research Institute is seeking an experienced Certified Clinical Research Coordinator with experience and general administrative skills. Must be a self-starter with strong communication skills, high organizational ability, and strong attention to detail. Proficient in Microsoft Office and experience with electronic medical records and various EDC systems. Home office is in Fleming Island, but travel may be required between sites in the greater Jacksonville area (including St. Augustine). Job Details include, but not limited to: Reviews and comprehends the protocol, investigator's brochure or package insert, lab manual, and pharmacy manual if applicable. Attends investigator meetings as required or requested by the PI or Medical Director. Attends the SIV and other required trainings. Collaborates with Regulatory to prepare regulatory submission documents as required. Reviews and assists in the preparation of study materials including, but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs, and other source documents. Establishes and organizes study files, study specific source documentation and other materials. Reviews and develops a familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, and privacy protections. Assists the PI with the development and implementation of recruitment strategies in accordance with IRB approvals. Conducts or participates in the informed consent process including discussions with potential research participants, answering study related questions, obtaining appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility. Registers research participants in the Clinical Trial Management System (CTMS) to ensure Coordinates and schedules participant tests, procedures, and visits. Collects data as required by the protocol and assures timely completion of Case Report Forms. Meets study timelines. Maintains adequate inventory of study supplies and investigational product. Follows Company and Sponsor requirements and operating procedures. Completes study documentation and maintains study files in accordance with Sponsor requirements and policies, including but not limited to: consent forms, source documents, notes to file (if applicable), case report forms, and accountability forms. Retains study records in accordance with Sponsor requirements and Company policies. Maintains effective and ongoing communication with the the Study Team, Sponsor representatives, research participants, and other key team members throughout the course of the study. Works with the Investigators and Medical Director to manage the day to day activities of the study including problem solving, communication and protocol management. Adheres to and supports all Federal regulations and policies instituted to safeguard protected health information (PHI). Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with Federal regulations. Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research to the Medical Director. Assists with compliance reporting requirements in accordance with Federal regulations and Sponsor requirements.' '

Benefit Conditions:

Only full-time employees eligible Benefits offered: Paid time off Health insurance Dental insurance Offers other types of insurance Retirement benefits or accounts Workplace perks such as food/coffee and flexible work schedules Others Work Remotely No This Job Is Ideal for

Someone Who Is:

People-oriented

• enjoys interacting with people and working on group projects Adaptable/flexible
• enjoys doing work that requires frequent shifts in direction Detail-oriented
• likes to focus on important details Self-starter
• can problem solve independently and is motivated to learn

Job Type:

Full-time Pay:

$64,000.00

• $70,000.

00 per year

Benefits:

Dental insurance Flexible schedule Health insurance Paid time off Professional development assistance Retirement plan Tuition reimbursement Vision insurance

Experience:

research coordinating: 1 year (Required)

License/Certification:

phlebotomy (Preferred)

Work Location:

In person