The Opportunity:

Precision Therapeutics, Inc. is a bio-technology start-up company located on the South Side of Pittsburgh. Precision assists Oncologists in choosing effective cancer therapies for cancer patients.  We are currently seeking a Clinical Research Associate II to join the Precision team. 

Duties & Responsibilities:

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.  The successful candidate must be self-motivated, a strong team player, highly organized, detail oriented, and be an excellent communicator. Start-up company employees thrive in a team-oriented, flexible, “I’m willing to do whatever it takes to be successful” culture.  A successful Clinical Research Associate II in this start-up environment will:

• Assist Precision’s Clinical Studies Team in the preparation of protocols, regulatory documents including informed consent forms, case report forms, and other study documents and materials.
• Assist the Director of Clinical Studies with project management activities such as developing/managing study timelines and budgets, preparing project reports, and communicating study progress.
• Monitor and track patient enrollment and study progress.
• For in-house managed clinical studies:
• In conjunction with the Clinical Studies Team, locate and select clinical investigators appropriate to the therapeutic area and phase of the study.
• Assess potential study sites to insure the facility, staff and patient population are sufficient for study conduct
• Assist the Senior Director of Clinical Trials with invoice tracking and monitoring as related to assigned trials
• Meet with Clinical Investigators and staff prior to study initiation 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
• Coordinate the shipment of required study supplies to sites
• Monitor study progress to assure compliance with protocol requirements and Good Clinical Practice by conducting site visits
• Perform site audits to include source document review
• Ensure the timely, accurate and complete collection and submission of study data
• Identify, address and resolve problems and issues as they might occur
• May perform data entry and data clean-up (quality control checks)
• At study completion
• Insure collection of all data and remaining study supplies for return
• Insure that the appropriate study documents are complete and properly filed
• Perform support tasks for clinical trials as needed, including but not limited to preparation and shipment of study supplies and report generation
• For Contract Research Organization (CRO) managed clinical studies:
• In conjunction with the Clinical Studies Team, identify and select qualified CROs
• Serve as the CRO point of contact for one or more externally managed clinical studies
• Work with the CRO to identify clinical investigators
• Coordinate with the CRO the shipment of required study supplies to sites
• Assist Precision’s Clinical Studies Team and/or CRO in problem solving and provide consultation on monitoring and study related activities
• Monitor CRO performance
• Organize and maintain electronic and paper files related to Precision’s clinical studies
• Provide support as required to Precision’s Corporate Compliance Program
• Participate in Clinical Studies strategic planning
• Assists with the development and/or maintenance of clinical studies infrastructure such as the drafting and/or reviewing of standard operating procedures
• May serve as a mentor for new employees and/or junior level staff
• Assist with data analysis and publication preparation activities

If you are seeking a dynamic, challenging atmosphere, that is never boring, with

a chance to make a difference and help cancer patients, email your resume to CRA2@ptilabs.com with the words “CRA II” in the subject of the email.

Qualifications:

• Education:
• Minimum of BSN/RN or Bachelors degree with a major in Life Sciences or a health related discipline or research certification (CCRA/CCRP)
• Required Experience: 
• 3-5 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials
• Preferred Experience:
• Prior experience working on a clinical trials team at a pharmaceutical company or at a CRO
• Oncology experience in a clinical or patient care setting
• Required Skills:         
• Able to work independently or in small teams
• Quick learner
• Highly organized and detail oriented
• Accurate and thorough
• Ability to travel up to 20%, project-driven
• Ability to work in a small company environment
• Well developed and effective communication skills , especially in the area of protocol writing
• Highly developed interpersonal skills
• Proficient with Microsoft Office Tools (Excel, Word, PowerPoint)
• An overall Attitude-, Aptitude-, Willingness to Learn- and Achievement-oriented approach and desire to get the job done right, whatever that takes.