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.