The Study Coordinator (SC) I provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those performed under applicable elements of Good Laboratory Practices (GLP) and/or Good Clinical Laboratory Practices (GCLP), under direct supervision. This includes, but is not limited to, project related support by creating study-specific documentation, assisting the Bioanalytical Principal Investigators (BP - Is) in tracking project timelines and deliverables, and c... more details
POSITION SUMMARY:
The Study Coordinator (SC) I provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those performed under applicable elements of Good Laboratory Practices (GLP) and/or Good Clinical Laboratory Practices (GCLP), under direct supervision. This includes, but is not limited to, project related support by creating study-specific documentation, assisting the Bioanalytical Principal Investigators (BPIs) in tracking project timelines and deliverables, and compiling project data tables according to project specifications.
DUTIES AND RESPONSIBILITIES:
• Assists in set-up activities for the bioanalytical study folders and study documentation
• Performs all study-related activities according to the appropriate Standard Operating Procedures (SOPs), Good GLP/GCLP (if applicable), and statements of work
• Participates in pre-initiation and other study related meetings, and assists Bioanalytical Principal Investigator (BPI) with scheduling meetings and drafting meeting minutes as required
• Drafts study-related documents including, but not limited to, sample analysis plans, study schedules and amendments to study documents, with guidance from supervisor and/or BPI
• Supports BPI in maintaining accurate and complete project documentation/study files, including study schedule, protocol, and correspondence, as applicable
• Participates in internal and external audits, as required
• Assists BPIs in tracking and resolution of deviations from in-study audits or client audits
• Provides support to the sample receiving team and administration including sample reconciliation
• Works closely with the data management team to test data transfers and report results to client
• Updates and maintains project tracking systems as appropriate
• Responsible for report preparation, including report/data table and figure preparation
• Assists BPI in submitting audit responses for QA audits as appropriate
• Assists in managing data transfer to clients as requested
• Assists BPI in monitoring study phases.
EXPERIENCE AND QUALIFICATIONS:
• Bachelor’s degree or higher in Science or Business required
o 3 or more years of relevant experience can be substituted for degree
• Minimum of 1 year of experience in customer-facing, technical support, and/or consultative roles highly preferred
• Minimum of 1 year of experience in a services organization preferred; experience in a clinical testing laboratory or contract research organization highly preferred
• Experience in life sciences, GxP, government contracting, or other regulated environment preferred
KNOWLEDGE, SKILLS AND ABILITIES:
• Excellent communication skills with the ability to organize, present, and articulate ideas both verbally and in writing
• A professional presence and strong interpersonal skills for interacting in a courteous, timely, and diplomatic manner with all levels of employees as well as external clients/customers
• Ability to receive, understand, and follow verbal and written directions
• Excellent organizational skills with the ability to prioritize workload and meet deadlines with an appropriate sense of urgency
• Proficiency in MS Office suite; familiarity with electronic file management using SharePoint Ability to multi-task and work productively in a demanding environment with changing priorities
• Attention to detail with demonstrated commitment to excellence and performance
PHYSICAL DEMANDS:
• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
WORK ENVIRONMENT:
• This position is performed in a traditional office environment with periodic requirements to work with laboratory personnel in their designated work areas.