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Clinical Research Coordinator Lead

STK enterprises Delray Beach, FL
  • Posted: over a month ago
  • $25 to $59 Hourly
  • Other

STK Innovation is looking for an experienced Clinical Research Coordinator to help start a research site in Delray Beach Florida. We are looking for someone who is a self-starter, motivated to join a growing organization, and be part of a new opportunity from Day 1.

The Opportunity

  • Join on the ground floor, and get the opportunity to create your own site with staff that you help choose

  • Lead different aspects of running a site, from leading trials to managing people

  • Work with an awesome group of people, who love their jobs

  • Competitive Pay with an opportunity to earn bonuses

  • Part-time or Full-time role available

Responsibilities of the Clinical Research Study Coordinator

  • Responsible for conducting clinical trials according to the protocol, ICH-GCP and other regulatory requirements under the auspices of the PI

  • Collect and complete feasibility questionnaires received from different Sponsors and CROs based on feedback from the PI

  • Flexibility to attend all investigator meetings, accompanying the PI/Sub-I, whether local or abroad

  • Responsible for the completion of initial regulatory document submission required by the Sponsor

  • Needs to have a thorough understanding of each protocol assigned, including study proceedings and timelines

  • Participates in all internal and external study meetings necessary for proper planning before and conduct during the trial(s)

  • Ensures all project assigned pre-study activities are completed, including but not limited to ICF and source documents reviewed, recruitment of subjects, equipment and supplies received, facilitate protocol training of study staff, etc

  • Works collaboratively with the investigators, study team, vendors, Sponsor, and study monitor to ensure that trial conduct is running smoothly Addresses issues as it occurs through proper notification and escalation channels

  • Coordinates all visits that pertain to the start-up, conduct, and close out activities of the trial with the study monitor to ensure that all study data is collected and complete; quality control of study execution and review of documents are being performed, maintained; all data queries are resolved

  • Set-up workflow and business processes for the research site

  • Lead patient recruiting activities alongside a recruiting support team

  • Responsible for maintaining all study documents through close-out

  • Assists Quality Assurance with hosting any and all external audits including, but not limited to, Sponsor, IRB, and FDA

  • May perform other job related duties as requested or required

QUALIFICATIONS AND REQUIREMENTS

  • Current BLS certification required

  • Bachelor’s degree and a minimum 6 months of clinical research experience required, 2 years of clinical research experience strongly preferred; or 1 year of commensurate clinical research experience required, 2-4 years of commensurate clinical research experience preferred

  • Registered Nurse (RN), Licensed Vocational Nurse (LVN), Medical Assistant (MA), or Phlebotomy Technician (CPT1)

  • Requires a thorough knowledge of the clinical research process, clinical trial management, ICH/GCP, GDP, and HIPAA

  • May be required to travel to satellite locations as needed or required to perform the job duties assigned

  • Must have a proper and reliable mode of transportation

  • Strong Interpersonal, verbal and communication skills

  • High attention to detail and a knack for creating high fidelity processes

  • Data quality must be the pinnacle of work performance as well as work ethic

  • Must be familiar with IRB, grant writing/approval, and business processes

  • Must be familiar with the research regulatory process

  • Technical experience required using Epic, OnCore, or other CTMS software

  • Working knowledge of Sharepoint is a plus (for documentation purposes)

  • Previous experience as a Clinical Research Coordinator required

STK enterprises

Why Work Here?

Lead a growing HVAC company that is expanding state-wide

We are a high-quality HVAC with great customer reviews seeking to expand statewide. Apply if you want to grow this company and your career.

Address

2279 Valleydale Rd. Ste 102, Birmingham, AL 35244
Delray Beach, FL
USA

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