Study Activation Coordinator

Requisition #: 585309
Location: Johns Hopkins All Children's Hospital, St. Petersburg, FL 33701
Category: Non-Clinical Professional
Work Week: Full Time
Weekend Work Required: No
Date Posted: Sept. 16, 2022

Come be a part of something bigger and work with the #1 Children's Hospital in Florida! We are Magnet designated & ranked nationally in 8 specialties by US News & World Report for 2021-2022!

Institute for Clinical & Translational Research

POSITION SUMMARY:

The Clinical Research Regulatory Coordinator II for Study Activation will be responsible to support study activation procedures and maintain diverse regulatory components for complex pediatric clinical and translational research protocols. This person will support a broad range of studies including investigator-initiated trials, pharmaceutical sponsored protocols, federal funded protocols such as NIH, FDA, NCI and other national and international consortium partners. Working closely with the Study Start Up Manager, Research Managers and study team, this person coordinates the protocol submission and perform ongoing protocol maintenance through internal and external governing bodies including the initial Institutional Review Board (IRB) applications following ICH/GCP guidelines. This person will coordinate submissions including IND/IDE applications, FDA annual reports, SAE reports, safety events, deviations, and other to the appropriate regulatory agencies. Supports the completion of comprehensive site qualification materials and study activation packets including FDA forms, HIPAA forms, biosafety forms, investigational drug data sheets, investigational brochures, study budgets, contracts and other. Register and maintain all regulatory and study activation tasks within business systems including project management tools, clinical trials management systems, patient reimbursement platforms, and other as assigned. The Coordinator works to ensure that all applicable changes in research and continuing reviews are submitted to the IRB during required milestones, updates are provided to the study team , and regulatory binders are maintained This person provides ongoing support for quality management activities including internal and external audits and monitoring visits as well a Correction Actions and Preventative Actions (CAPAs).

LOCATION: St. Petersburg, FL

HOURS: Full time, Days 8a - 4p

QUALIFICATIONS:

• Either one of the following is required:
  • Bachelor's degree with 4 years' experience in academic or industry-based clinical research or equivalent healthcare experience OR
  • Associate's degree and 8 years' experience in academic, industry-based clinical research or equivalent healthcare experience
  • Licensure/Certification: SOCRA or AACR certification within 12 months of hire
  • Computer proficiency in using Microsoft Office including Word, Excel, and Outlook
  • Ability to communicate effectively, both verbally and in writing; ability to read, write, speak and understand English
  • Excellent organizational and time management skills
  • Ability to work effectively in teams as well as work autonomously, seeking appropriate supervision
  • Familiarity with NIH, GCP, OHRP and federal regulations for human subject participation in clinical research

  
  
  Johns Hopkins Health System and its affiliates are an Equal Opportunity / Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.
  
  Johns Hopkins Health System and its affiliates are drug-free workplace employers.
  
  We are committed to providing a healthy and safe environment for our patients, visitors and staff members. The Johns Hopkins Hospital has a tobacco-free at work policy. Employees must refrain from using any tobacco products during their work shifts - including while at lunch or on breaks, and whether they are on or off campus.