Program Manager Clinical Research Coordinator

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General Summary/Purpose:

The Manager of the Research Program will coordinate prospective clinical research studies across multiple sites as part of developing a multi-site, national, musculoskeletal-focused clinical practice based-research network. The position will coordinate the implementation of research protocols related to these studies across dozens of sites; develop standard operating procedures to govern these processes; oversee sites’ efforts to screen and enroll patients and provide continued monitoring of these studies ensuring that all protocols are followed; and provide status reports related to study conduct, billing, and other regulatory components.

Specific Duties & Responsibilities:

  • Provide support and coordination for research staff across multiple sites during the planning phases of new trials. This would include protocol development, consent and case report form development through enrollment, study completion and post study closure.
  • Accountable for the overall administration and outcomes for clinical research (e.g. clinical trials) requiring advanced-level knowledge and skills to manage a diverse portfolio of research responsibilities.
  • Oversight of sites’ screening, recruitment, protocol adherence, schedule patient visits and assessments, as well as telephone follow up
  • Assist with preparation of IRB submissions.
  • Coordinate all duties pertaining to opening new trials.
  • Coordinate handling of relevant patient biological specimens and follow protocol requirements.
  • Blood sample processing to include obtaining specimens by phlebotomy and appropriate handling and labeling.
  • Coordination of research meetings across sites, including site initiation visits, as well as providing updates on the study progress and issues related to the research.
  • Prepare regulatory reports and maintain all regulatory binders for enrolling trials and trials in follow-up phase.
  • Prepare and maintain individual participant study binders.
  • Adhere to FDA regulatory compliance and regulations, if needed.
  • Maintain appropriate correspondence with the IRB. Complete and submit IRB Change in Research Reports, including adverse events, protocol deviations and protocol amendments.
  • Complete and submit annual IRB continuing review reports.
  • Ensure quality, consistency, and accuracy in the conduct of research trials.
  • Maintain the research data base including data entry
  • Assist in clinical trial design.
  • Oversee study-wide data collection including patient contact for enrollment and follow-up.
  • Prepare and submit annual continuing review reports
  • Oversee record management for research studies. Set up database, as well as processing systems and efficiencies for reporting purposes using Electronic Data Capture (EDC) systems such as Redcap; Tableau; Excel; MS Access, or similar electronic systems
  • Oversee budget development, as well as budget expenditures for study operations. Lead and Participate in weekly research conferences.
  • Conduct all study close out related procedures including IRB termination reports

 Education and Experience:

  • Required: Bachelor’s degree in related discipline required plus at least 5 years of experience as a research study coordinator.
  • Preferred: Master’s Degree in health related field or equivalent work experience; and/or Registered Nurse or higher degree.

Location: Boca Raton, Florida or Birmingham, Alabama

Salary: $75k to $95K

Minimum Qualifications (Mandatory):

  • Ability to work independently and manage multiple tasks, detail orientated, self-motivated.
  • Ability to be flexible in work conditions, hours and work well in team setting.
  • Prepare study-related budgets and assist with financial reconciliation via a Clinical Trial Management System
  • Proficiency in electronic data capture (EDC) systems, word processing, database, spreadsheet software- ability to use a laptop and personal computer.
  • Possess excellent oral and written communication skills.
  • Excellent organizational skills, strong interpersonal skills, and ability to multitask.

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