Clinical Project Coordinator
- Gaithersburg, Maryland
- Pharma & Biotech, Clinical Research, Medical Affairs, Operations
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
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
- 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.
- 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.