Senior Study Coordinator

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

13h•Onsite

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
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

Nice To Haves

Master’s degree is preferred
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

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