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MS

Senior Study Coordinator

MESO SCALE DIAGNOSTICS, LLC.·Gaithersburg, Maryland

$67,900 - $101,000/yr·Full Time·On Site·2-5 yrs·Posted 3 months ago
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About the role

The Senior Study Coordinator supports bioanalytical laboratory studies by drafting protocols, managing study documentation, and performing quality control reviews. They work closely with Principal Investigators to track project timelines, deliverables, and ensure compliance with GLP and GCLP standards.

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
MS

Hiring organization

MESO SCALE DIAGNOSTICS, LLC.

Founded in 1995, Meso Scale Discovery (MSD) is a global leader in the development, manufacture, and commercialization of innovative assays and instruments for the measurement of molecules in biological samples. MSD’s proprietary MULTI ARRAY technology enhances medical research...

Salary listed on 1 job
IndustryBiotechnology Research
TypePrivately Held
Size1,001-5,000 employees
Explore employer profile
  • 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

    • o 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 [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.

    Requirements

    Candidates must possess a bachelor's degree in a scientific discipline and at least 2 years of experience in biological sample testing or assay development. Proficiency in GLP/GCLP regulations and strong organizational and communication skills are required.

    • bachelor degree
    • postgraduate degree
    • SharePoint
    • Organizational skills
    • Communication skills
    • Project management
    • Good Laboratory Practices
    • Data management
    • Technical support
    • Good Clinical Laboratory Practices
    • Protocol drafting
    • MS Office suite
    • Analytical background
    • Ligand-binding assays
    • Quality control review
    • Scientific fundamentals
    • Bioanalytical laboratory support
    • Sample analysis plans

    Posting details

    Employment type
    Full Time
    Work arrangement
    On Site
    Experience
    2-5 yrs
    Salary
    $67,900 - $101,000/yr
    Location
    Gaithersburg, Maryland
    Posted
    Apr 20, 2026
    Application
    Employer website

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    Market context

    Maryland medical office admin roles stay steady

    In Maryland, medical office administration roles are typically supported by steady demand from clinics, practices, and outpatient settings that need reliable front-office and billing support. These roles are competitive because employers often look for candidates with medical terminology knowledge, basic billing and coding skills, and comfort with standard office software. Review the AI-summarized requirements and benefits on this platform to save research time, then tailor your application to show one year of medical office experience and any billing or software tools you’ve used.

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