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Clinical Project Coordinator

Location: Gaithersburg, Maryland Salary: competitive
Sector: Pharma & Biotech, Clinical Research, Medical Affairs, Operations Type: Contract

Clinical Project Coordinator

Clinical Project Coordinator Position Summary:

  • Responsible for supporting Clinical Operation Team members with the tasks associated with implementation and conduct of clinical studies.
  • Qualified candidates will demonstrate the ability to coordinate and prioritize multiple tasks, have good computer skills, and practical clinical trial experience.

Major Duties and Responsibilities of Clinical Project Coordinator:

  • Maintain trial master file, study site records and files and ensure compliance with applicable SOPs o Create, implement, and maintain systems to track study metrics and general information (ex. OPAL and IMPACT, etc.)
  • Coordinate generation of study metric reports and action logs o Review of essential study documents o Process study-related documents and materials - to include collation, filing, routing coordination of third-party provider document shipments
  • Initiate contract/budget requests and track ongoing status
  • Schedule team meetings and prepare agendas and minutes
  • Prepare and distribute study-related correspondence
  • Organize and ship study supplies to clinical sites
  • Participate in identification and selection of clinical study sites, including conducting searches of web-based databases
  • Develop study specific procedures and tools o Assist clinical operations team with study management
  • Participate in vendor selection and ongoing vendor management o Generate purchase orders, process vendor invoices and assist in tracking spend against approved budget
  • Assist in the organization of advisory boards and investigator meetings. Track approvals and completion of required documents.
  • Assist in the clinical trial insurance process.
  • Track approvals, revisions and renewals of certificates
  • Perform other functions as necessary or as assigned

Requirements/Qualifications:

Education: Bachelor's Degree preferred

Experience: 2-3 year's clinical trial experience and at least 1 year experience in an office or laboratory environment

Special Skills/Abilities:

  • Professional demeanor and ability to work as a team member
  • Experience with Microsoft Office Suite (Word, Power Point, Excel)
  • Ability to coordinate and prioritize multiple tasks o Demonstrated verbal and written communication skills
  • Demonstrated interpersonal and problem solving skills o Proactive approach and the ability to act independently, or as part of a diverse team
  • Understanding of ICH, GCP and relevant regulatory requirements
  • Familiarity with drug names, diagnoses and medical/research terminology
  • Ability to work as part of a global team
  • Willingness to travel to attend periodic meetings.

Supervision:

  • Work under a moderate level of oversight of Sr CPM or AD/D Clinical Operations
  • Develops approach to solutions and seeks guidance as appropriate
  • Work is reviewed for soundness of technical judgment, overall adequacy and accuracy

Sthree US is acting as an Employment Business in relation to this vacancy.