Client Services Study Coordinator

Job Description

Duties and Responsibilities:

• Point person for the facilitation of Clinical Trial Testing; bridges the sponsor and trial execution by managing client relationships and overseeing trial progress.
• Manage all aspects of assigned trials under your purview with direction from the lead Project Manager.
• Communicate with clinical and regulatory affairs and translate information effectively.
• This includes all matters; technical, facilitation of workflow, testing sites and customer relations.
• Maintain up to date and accurate logs reflecting testing status.
• Provide metrics to the site, customer or sponsor as requested.
• Resolve issues as they arise.
• Report critical issues to site leadership.
• Provide updates as requested.
• Develop SOPs supporting clinical trial testing as required.
• Maintain Study Binders/Trial Master File (TMF) as required per GCP.
• Perform Quality checks on all deliverables to customers.
• Partner with other employees to ensure second QC checks when required.
• Training other personnel as required.

Education and Experiences:

• Associate or bachelor’s degree (AA or BS).
• Two years’ experience and/or training in related field such as in a Contract Research Organization, University or Medical setting, or other equivalent experience.
• Experience working in regulated environments and familiarity with CAP/CLIA/CDx regulatory compliance and quality assurance standards.
• Minimum of 2 years Study Coordinator or Clinical Research or Trial experience required.

Knowledge, Skills & Abilities:

• Demonstrated proficiency in computer skills, such as word processing, Excel and information systems.
• Excellent verbal and written communication skills, customer service and problem-solving skills.
• Strong attention to detail and understanding of regulatory compliance, GCP and HIPAA.
• Knowledge of medical terminology.
• Positive attitude and the ability to adapt and be flexible in a fast-paced and evolving work environment.
• Organizational skillset, process driven, and able to manage multiple tasks with flexibility and ease.