Clinical Research Coordinator - Team Lead (Research Associate)

The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment require management of complex clinical research studies involving a very vulnerable and sick population.

The Clinical Research Coordination Team Lead oversees and manages the day to day operations of clinical research activities for studies conducted at the OHSU Knight Cancer Institute.

Leadership responsibilities of the CRC Team Lead position:

• To be an oncology disease site knowledge expert for the teams that they lead;
• Must have a strong understanding of how clinical and research operations work within the clinics/hospitals that their team works in and departments they collaborate with;
• Must have the ability to cover all roles that they oversee;
• Participates, with close collaboration of the disease site manager, in the strategic planning and financial management of the disease team they lead;
• Is the first point of contact for the study team members regarding operational aspects of clinical research, to resolve issues and remove obstacles for study team members, sets priorities for workload, and identifies opportunities for process improvement;
• Manages coverage issues related to sick calls, vacation time, and may fill in to assist with responsibilities following a position vacancy.
• Does not maintain direct reporting responsibility for team members.

In addition to leadership responsibilities, this position maintains direct clinical research study management duties. Study management responsibilities include:

• Coordination of all aspects of a study as specifically outlined in the protocol and compliance with applicable regulations, including Good Clinical Practice;
• Works collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities;
• Maintains accurate, complete and timely records on research subjects which may include preparation of source documentation and clinical research data/case report forms;
• Represents the investigator during monitor visits and on-site audits conducted by the sponsor or sponsor representative;
• May assist the Regulatory Project Manager with the IRB submission, to include preparation of consent forms and other documents required for IRB review.
• Maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research.

Team Lead Responsibilities Non-Study Specific (40%)

Team Lead Responsibilities Study Specific (30%)

Clinical Research Responsibilities (25%)

Additional duties as assigned by Clinical Research Manager or Program Director (5%)

Masters degree with major courses in the relevant field and three years of relevant experience -or-

Bachelor's Degree (4 yr) with major courses in the field of research and five years of relevant experience -or-

Bachelor's or Master's degree and prior experience with Knight Clinical Research Management department.

Required competencies:

• Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time
• Excellent communication, analytical and organizational skills:both written and verbal
• Ability to work independently and as part of a team while being collaborative in resolving problems
• Proficiency with computers running Windows, PC applications, and the Microsoft Office suite, e.g., Excel, Outlook, Word and PowerPoint
• Excellent customer service skills, both on the phone and in person
• Energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships
• Strong attention to detail
• Strong understanding of the scientific method
• skills plus exercises sound judgment in taking independent action and seeks to advise as appropriate;
• Motivation to identify and lead process improvement efforts
• Strong problem-solving skills

• Bachelors or Master'sdegree in relevant field
• Some clinical trial knowledge with at least 5years of research experience
• Prior study management and clinical research coordination experience
• Prior experience supervising direct reports or mentoring junior staff
• Experience working in an office environment
• Familiarity with medical terminology
• CCRP or ACRP Certified

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