Qualifications:

• Advanced degree or certification as research professional is preferred, bachelor’s degree with at least 5 years experience in clinical trials research (oncology experience is a plus) is acceptable
• Excellent organizational skills
• Strong interpersonal, teamwork and presentation skills
• Ability to work independently
• Ability to make decisions using good judgment, and appropriately including other team members
• Ability to follow-through on projects and to oversee and direct external service providers

• Required Skills:         
• Excellent organizational skills
• Strong teamwork skills
• Well developed and effective communication skills
• Able to work independently or in small teams
• Quick learner
• Highly developed interpersonal skills
• Accurate and thorough
• Proven project management ability
• Medical writing skills
• Excellent presentation skills
• Ability to travel up to 20%, project-driven
• Ability to work in a small company environment
• 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.

 General description:

Coordinate all efforts for trials, serving as the key operational interface with both internal and external departments and service providers

Drive all aspects of the trials from planning, execution, closure, and publication, directing timelines and overseeing budget, ensuring adherence to good clinical practices (GCPs) and all applicable regulatory guidelines

 Duties & Responsibilities:

• Serve as the project coordinator for multiple clinical trials that are run externally through Contract Research Organizations (CROs) and those that are run in-house
• For externally-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
• Oversee development of written protocols, regulatory documents including the consent form, and data collection tools, referring to outside experts/consultants as appropriate
• Work with the CRO to identify clinical investigators
• Coordinate with the CRO the shipment of required study supplies to sites.
• Coordinate meetings and presentations for the protocol team (in-house and CRO)
• Work with in-house laboratory, regulatory, information technology groups and senior executives to ensure the required infrastructure, procedures and programs are developed to conduct the trials and to provide for reporting of trial progress
• Ensure compliance with HIPAA, GCPs and other applicable regulatory requirements
• Manage trial timelines, identifying problem areas and proposing and implementing solutions
• Provide consultation on monitoring and study related activities.
• Monitor CRO performance
• Specify reports that CRO provides to the company to assess progress of the trials
• Track invoices and payments
• Assist with investigator payment processes

• For clinical studies managed in-house:
• 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 ensure the facility, staff and patient population are sufficient for study conduct.
• Assist the Senior Director of Clinical Trials to negotiate the study budget and any other contract agreements required.
• 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 development of written protocols, regulatory documents including informed consent forms, case report forms, and other study documents and materials.
• Coordinate the shipment of required study supplies to sites.
• Develop specifications to IT and lab departments for required in-house infrastructure necessary to accomplish goals of the trials
• Perform site audits to include source document review and to ensure compliance with protocol requirements and Good Clinical Practices
• Ensure the timely, accurate and complete collection and submission of study data
• Serve as the primary contact for study-related questions from participating sites
• Identify, address and resolve problems and issues as they might occur
• 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
• Develop and manage study timelines and budgets, develop and prepare reports to monitor, track and communicate patient enrollment and study progress
• Organize and maintain electronic and paper files related to Precision’s clinical studies
• Serve as a primary strategic planner for the Clinical Trials group
• Responsible for development and/or maintenance of standard operating procedures
• Coordinate the activities of junior level staff.
• Assist with data analysis and publication preparation activities
• Serve as liaison to other departments from the Clinical Studies group, providing training and information both informally and formally in presentations and meetings

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 “Project Leader” in the subject of the email.