Senior Study Coordinator

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 67,900 - 101,000; Full time

Job summary

Meso Scale Diagnostics LLC is seeking a Senior Study Coordinator to support the Bioanalytical Laboratory in GLP/GCLP-compliant studies. You will assist BPIs, track timelines, and perform QC on study data, while managing multiple studies with meticulous documentation.

The role requires strong scientific background, effective communication, and ability to liaise across departments and with clients. Work is in an office environment with laboratory interaction as needed.

Qualifications

• Bachelor’s degree in biology, chemistry, or related scientific discipline, or equivalent work experience required.
• Master’s degree preferred.
• Experience in GLP/GCLP context is advantageous.

Responsibilities

• Drafts protocols, SAPs, amendments, reports and study schedules independently.
• Reviews records for compliance with SOPs, GLP/GCLP requirements.
• Communicates with other departments and clients on timelines and deliverables.

Skills

Scientific fundamentals

Communication skills

MS Office proficiency

Documentation & archiving

Education

Bachelor’s degree in biology/chemistry or related

Master’s degree preferred

Tools

MS Office

SharePoint

Job description

POSITION SUMMARY:

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.

DUTIES AND 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

EXPERIENCE AND QUALIFICATIONS:

• Bachelor’s degree in biology, chemistry, or other related scientific discipline, or equivalent work experience required
• Master’s degree is preferred
• 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

KNOWLEDGE, SKILLS AND ABILITIES:

• 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

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.

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $67,900 to $101,000. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non‑discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company’s overall success.

BENEFITS SUMMARY:

At MSD, we offer a comprehensive benefits package to support our employees’ well‑being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company‑paid short‑and‑long‑term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT:

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.