USA-Clinical Contract Coordinator II (Clinical)

The Fountain Group LLC

Cambridge, MA

JOB DETAILS
SALARY
$35–$42 Per Hour
SKILLS
Banking Operations, Biology, Biomarkers, Biomedicine, Biotech and Pharmaceutical, Case Report Form (CRF), Chain of Custody, Clinical Information Systems, Clinical Laboratory, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Clinical Trial Management, Contract Management, Data Collection, Documentation, Electronic Data Capture (EDC), Equipment Maintenance/Repair, GCP (Good Clinical Practices), Health Science, ICH Regulations, Informed Consent, Inventory Management, Laboratory Equipment, Laboratory Information Management System (LIMS), Laboratory Management, Laboratory Operations, Maintain Compliance, Medicine, Operational Support, Operations Management, Pre-Clinical, Process Improvement, Project/Program Management, Public Health, Record Keeping, Regulations, Specimen Collection, Specimens/Samples, Standard Operating Procedures (SOP), Status Reports, Symmetric MultiProcessing (SMP) Computing, Traceability
LOCATION
Cambridge, MA
POSTED
28 days ago
The Fountain Group is currently seeking a USA-Clinical Contract Coordinator II (Clinical) for a prominent client of ours. This position is located at 350 Water Street, Cambridge, MA. Details for the position are as follows:
 
Clinical Contract Coordinator II (Clinical)
Location: Cambridge, MA (Onsite)
Pay Rate: $35–$42/hr
Duration: 12 Months (High Possibility of Extension)

Job Description

Seeking a Clinical Contract Coordinator II to support biospecimen management operations for pre-clinical and clinical research programs. This role is responsible for coordinating the complete biospecimen lifecycle, laboratory operations, LIMS management, sample tracking, and clinical study support while ensuring compliance with GCP, GCLP, and regulatory standards.

  • Coordinate end-to-end biospecimen lifecycle including receipt, registration, processing, storage, shipment, inventory management, and archival
  • Register and maintain biospecimen records within LIMS (Watson) and ensure accurate sample traceability
  • Create study designs and maintain biospecimen inventories, laboratory equipment, and consumables
  • Monitor biospecimen chain of custody and resolve sample discrepancies with study teams
  • Develop Biospecimen Management Plans (SMPs) and support biospecimen collection, storage, and shipping workflows
  • Review clinical study documents including protocols, informed consent forms, eCRFs, laboratory manuals, and data collection strategies
  • Coordinate with central laboratories, biorepositories, bioanalytical vendors, and clinical study teams
  • Maintain biospecimen documentation within the electronic Trial Master File (eTMF)
  • Support laboratory quality systems, equipment maintenance, SOP development, audits, inspections, and process improvement initiatives
  • Generate biospecimen status reports and monitor sample tracking from collection through destruction
  • Ensure compliance with GCP, GCLP, CLIA, CAP, and applicable regulatory requirements

Education

  • Bachelor's or Master's degree in Biological Sciences, Biomedical Sciences, Biotechnology, Clinical Laboratory Science, Public Health, Life Sciences, or a related discipline
  • Minimum 3 years of experience in biospecimen management, clinical laboratory operations, or clinical trial sample management

Required Skills

  • Biospecimen lifecycle management
  • Biospecimen management and laboratory operations
  • Laboratory coordination and sample management
  • Laboratory Information Management Systems (LIMS), including Watson
  • Clinical trial sample management
  • Biospecimen collection, processing, storage, shipment, and inventory control
  • Chain of custody and specimen traceability
  • Electronic Trial Master File (eTMF)
  • Electronic Case Report Forms (eCRF)
  • Clinical trial management systems (CTMS) and Electronic Data Capture (EDC)
  • Biospecimen Management Plan (SMP) development
  • Clinical protocol review
  • GCP, GCLP, CLIA, CAP, and ICH-GCP compliance
  • Laboratory equipment and inventory management
  • Vendor and central laboratory coordination

Preferred Skills

  • Global multi-site clinical trial experience
  • Biospecimen banking or biorepository operations
  • Translational medicine support
  • Biomarker, PK, or ADA sample management
  • Project management
  • Audit and regulatory inspection support
  • SOP development and process optimization


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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/