Senior Study Coordinator

Meso Scale Diagnostics, Llc. • Gaithersburg, MD

126d • $67,900 - $101,000

About The Position

The Senior Study Coordinator (SC) provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those performed under applicable elements of Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP), with minimal 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 performing Quality Control review of study data. The Senior SC works closely with the BPIs to support the execution of BAL studies.

Requirements

• Bachelor's degree in biology, chemistry, or other related scientific discipline, or equivalent work experience required
• Minimum of 2 years of experience in biological sample testing or reagent/assay development is required; experience in a clinical testing laboratory or contract research organization is highly preferred
• Experience in customer-facing, technical support, and/or consultative roles preferred
• Training in and experience with GLP and/or GCLP is preferred

Nice To Haves

• Master's degree is preferred
• Strong scientific fundamentals and analytical background
• Understanding of ligand-binding assays
• 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
• Ability to communicate/delegate tasks/projects in a clear, concise manner that is easily understandable to all levels of support
• 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

Responsibilities

• Independently drafts protocols, sample analysis plans (SAPs), protocol and SAP amendments, bioanalytical reports, and study schedules, using proposal outline or client-supplied information
• Reviews study records and reports for compliance against protocol, Standard Operating Procedures (SOPs), and GLP/GCLP requirements, as applicable
• Serves as a contact in communication and interaction with other departments and clients on project timelines and deliverables
• Participates in pre-initiation and other study related meetings as required
• Performs Quality Control review of study data and independently works with BPIs to resolve any identified issues
• Manages study documentation for multiple concurrent, moderate to high complexity projects
• Assists BPIs in analyzing and evaluating data for reports and managing data transfers to clients as requested
• Works closely with the data management team to create mock reports and test data transfers and report results to client
• Maintains well-documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable
• Prepare study files for Archiving at the conclusion of the study
• Assists BPI in monitoring study phases, including updating and maintaining project tracking systems as appropriate
• Adheres to applicable principles of GLP and GCLP

Benefits

• Medical, dental, and vision coverage, along with prescription benefits
• 401(k) plan with company matching
• Flexible spending accounts
• Company-paid short- and long-term disability insurance
• Group life and accidental death and dismemberment insurance
• Paid vacation, paid sick leave, paid holidays, and paid parental leave
• Employee assistance program
• Fitness club membership contribution
• Pet insurance
• Identity theft protection
• Home and auto insurance discounts
• Optional supplemental life insurance

What This Job Offers

• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree