Job Title: Clinical Study Coordinator - Phase 1 (Office-based)
Overland Park, KS
Computers, Software, Customer Service and Call Center, Information Technology, Installation, Maintenance, and Repair, Executive Management, Research & Development, Medical, Nonprofit and Volunteer Services
Clinical Study Coordinator - Phase 1 (Office-based)
JOB DESCRIPTION PURPOSE
Manage Projects and Trial Master File and ensure that all project work is completed in accordance with SOPs, policies and practices. The position will be office-based stationed in Overland Park, KS.
Monitor and coordinate efforts of cross-functional project teams within the phase I clinic.
Meet with study team members on a regular basis regarding project tasks to ensure project milestones are met.
Collect information on team performance against contract, customer expectations, and project baselines.
Lead problem solving and resolution efforts.
Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
Develop and oversee maintenance of internal study teams and project plans.
Ensure out of scope are communicated to sponsor during the study, priced and incorporated into project budget, where required.
Produce and distribute reports and presentation materials.
Train and mentor junior project support staff.
Provide input to line managers of their project team members' performance relative to project tasks.
Partner with other Project managers to develop and implement process improvements
Prepare and present project information at internal and external meetings.
Ensure that work is conducted in compliance with standard processes, policies and procedures and meets quality and timeline metrics.
Creation of study source documents for use within the clinic
Work closely with study physicians to ensure qualified volunteers are enrolled into clinical research trials
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong communication and interpersonal skills
Good problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good teamwork skills
Excellent customer service skills
Ability to work with minimal direction
Strong software and computer skills, including MS Office applications
Ability to establish and maintain effective working relationships with colleagues and team members
Qualifications & Requirements
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
RN, BSN (preferred) or Bachelors degree in life sciences or related field with 5 years clinical research experience (key CRO/Pharmaceutical operational function, eg, data management, clinical operations, laboratory, pre-cinical) and 2 years project management experience; or equivalent combination of education, training and experience