Precision Therapeutics, Inc. is a diagnostics services company dedicated to providing physicians and patients with actionable clinical information to personalize cancer treatments.  We are currently seeking a Clinical Research Associate I. 

The successful candidate will join a talented team of clinical research professionals in the design and execution of clinical studies designed to personalize cancer therapy. 

If you are seeking a dynamic, challenging atmosphere (that is never boring), with the opportunity to make a difference to help oncologists and their patients email your resume to PTIResumes@ptilabs.com with the words “CRA I” in the subject of the email.

A successful Clinical Research Associate I in this start-up environment will:

Monitoring Functions:

• Perform site qualification, initiation, monitoring, and close-out visits for source document review and regulatory compliance
• Maintain scientific communications with investigators and site staff
• Assess potential study sites to ensure the facility, staff, and patient population are sufficient for study conduct
• Meet with clinical investigators and staff prior to study initiation to train and to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete
• Manage site budget, invoices, and payments according to the finalized contract
• Identify needs and coordinate the shipment of required study supplies to sites
• Monitor study progress to assure compliance with protocol requirements and all applicable regulations
• Coordinate site contract efforts
• Ensure the timely, accurate and complete collection and submission of study data
• Identify, address, and resolve problems and issues as they might occur
• Draft and follow to resolution all data queries identified
• Maintain site regulatory binders/materials
• Ensure ongoing collection of all data and remaining study supplies

Protocol Development Duties:

• Review site specific regulatory documents including informed consent forms
• Assist in the Site Specific IRB approval process
• Assist in the development of study documents and materials to increase efficiency and quality of the trial
• Assist in the preparation of protocol documents, consent forms, case report forms, and amendments

Data Management Duties:

• Participate in electronic data capture (EDC) system specification building and testing
• Assist in the development of site data entry training
• Conduct data entry, site data review, cleaning and screening of data, data audits
• Monitor and track patient enrollment and study progress
• Identify, address and resolve problems and issues as they might occur
• Organize and maintain electronic and paper files related to Precision’s clinical studies
  
  

General Duties

• Provide support as required to Precision’s Corporate Compliance Program
• General knowledge of all applicable regulations (GCP, ICH, CFR, OHRP, HIPAA)
• Assists with the development and/or maintenance of clinical studies infrastructure such as the draft and/or review of standard operating procedures
• Assist with data analysis and publication preparation activities
• May participate on inter- or intra- department teams
  
  Qualifications:
  

• Education:
  • Minimum Bachelors degree with a major in Life Sciences or a health related discipline
    
• Required Experience: 
  • 1-3 years experience in clinical/scientific research, or medical devices/pharmaceutical clinical trials
• Preferred Experience:
  • Prior experience working on a clinical trials team at a pharmaceutical or device company
• Required Skills:
  • Ability to travel up to 50-60%, project-driven
  • Ability to work in a small company environment
  • Well developed and effective communication skills
  • Highly developed interpersonal skills
  • Proficient Microsoft Office Tools (Excel-Spreadsheets & Pivot Tables, Word, PowerPoint)
  • Valid Driver’s License