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.
Requirements summary
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.
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
o Master’s degree is preferred
Benefits
Paid vacation
Paid holidays
Medical coverage
Paid parental leave
Flexible spending accounts
Vision coverage
Dental coverage
Short-term disability insurance
Long-term disability insurance
401(k) plan
Employee assistance program
Paid sick leave
Pet insurance
Accidental death and dismemberment insurance
Identity theft protection
Prescription benefits
Group life insurance
Fitness club membership contribution
Home and auto insurance discounts
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.
