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Clinical Project Coordinator
Ref No.: 18-01003
Location: Cambridge, Massachusetts
Position Type:Direct Placement
Start Date: 02/26/2018
Job Title: Clinical Project Coordinator
Job Duration: Permanent
Job Location: Cambridge, MA

The Clinical Project Coordinator is responsible for assisting the study team in running the day to day operational activities of clinical studies. The individual will be responsible for the coordination, tracking and management of daily activities for multiple clinical studies to support both the internal team and CROs.

Essential Functions and Duties
  • Works directly with internal clinical lead and internal and external medical experts to optimize and implement clinical studies
  • Assists in Protocol review to ensure seamless integration between clinical objectives and study performance.
  • Assists with CRO and vendor selection, participates in discussions related to study scope and budget.
  • Participates in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.
  • Clinical study team member: works closely with the Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials.
  • Responsible for reconciliation of monthly invoices/PO management. Also responsible for investigator and vendor payments for in-house studies.
  • Works closely with the Clinical Project Manager and Legal to review and approve confidentiality agreements, clinical trial agreements and site specific study budgets
  • Tracks study status, enrollment, regulatory documentation, and site startup status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
  • Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
  • Responsible for setup, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file.
  • Coordinates TMF transfer with CROs.
  • Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
Skills and Experience
  • Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas. 1- 2 years of biopharma industry experience in clinical research operations required.
  • Experience in running one or more clinical studies in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology.
  • Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
  • Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
  • Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
  • Demonstrated ability to work independently with exceptional organization and attention to detail.
  • Excellent oral and written communication and presentation skills.