Coordinator of Special Projects - Vendor Services/Device Trials

Schedule: 1st Shift

POSITION:  Coordinator of Special Projects-Vendor Services/Device Trials

POSITION DESCRIPTION:  The Coordinator of Special Projects-Vendor Services/ Device Trials (Coordinator), under the general direction of the Chief Executive Officer, demonstrates critical thinking skills, judgment and leadership.  The Coordinator oversees, manages and maintains all administrative, regulatory and budgetary documentation pertaining to device trials, sample procurement, QA validations, assay validations and clinical research studies collectively referred to as Vendor Services. Provides guidance to administration, principal investigators, clinical investigative teams and study sponsors in accordance with accreditation authorities, policies, procedures, established standards and administrative policies. The Coordinator completes position responsibilities by following these guidelines & protocols within the appropriate time frame; demonstrates good skills in all forms of communication. Works well with others in a spirit of teamwork and cooperation, is detail oriented with the ability to collect, compile and analyze information. Can work independently on multiple tasks and manage time effectively.  Maintains education and development appropriate for position.  Supports mission, vision and values.  Other duties as requested.

• Acts as an administrative liaison between study sponsors, principal investigators, clinical investigative teams and IRB.
• Ensures that administration is kept apprised of proposed, pending and current studies.
• Assesses all submitted Vendor Services contractual agreements and collaborates with sponsors regarding revisions prior to administrative review.
• Responsible for preparation and submission of IRB required materials to include study submission start up and close out, change in protocol documentation and amendment letters.
• Provides Vendor Services financial and budgetary reports.
• Monitors and interprets Vendor Services revenue and cash flow.
• Manages Vendor Services monthly billing and payments.
• Monitors and communicates to administration Vendor Services staff resources and timeframes required for proposed, pending and current studies.
• Collaborates with administration and clinical investigative teams to determine proposed study budgets and associated study expenses.
• Ensures that GCP training is provided and documented for qualified investigative clinical staff.

EDUCATION: The Coordinator must possess a Bachelor of Science Degree (Chemistry, Biology, etc.).   Experience in a clinical laboratory is preferred.

WORK ENVIRONMENT AND HAZARDS: The Coordinator may have exposure to communicable diseases, bloodborne pathogens, toxic substances, and other conditions common to a health care environment.

PHYSICAL DEMANDS: The Coordinator position requires prolonged standing, some walking and sitting, some bending, stooping, and stretching, eye-hand coordination and manual dexterity, ability to distinguish letters, numbers and symbols, use of computerized instruments, computer terminals, and other equipment common to a clinical laboratory.  May require lifting up to 30 pounds.

CONTACTS: The Coordinator may have frequent contact with hospital employees, physicians, pathologists, nursing personnel, visitors, laboratory personnel, vendors, and regulatory or accrediting agencies.

SPECIAL EQUIPMENT, SKILLS, OR OTHER REQUIREMENTS: The Coordinator must have superb written & verbal communication skills. Experience working with executives at the sponsor companies. Needs excellent math/finance skills and very knowledgeable with Excel. The ability to properly prioritize tasks and complete them in a timely manner.  Ability to adapt to changing workload and stressful situations.   Experience in pre-analytical sample/specimen processing and clinical lab testing.

TO APPLY:

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