POSITION SUMMARY

Oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; may supervise clinical research staff.

EDUCATION:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

WORK EXPERIENCE:

Clinical Research (3 Years)

SKILLS:

Supervision

REQUIRED QUALIFICATIONS:

• Basic Life Support certification must be obtained within one month of hire date.
• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement).

EDUCATION:

Master’s degree

WORK EXPERIENCE:

No additional work experience beyond what is stated in the Required Qualifications section.

SKILLS:

Clinical Research Management, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS)

• Manages protocol study start up and study launch, submission, and maintenance of essential regulatory documents.
• Assists in budget review and invoice tracking.
• Assists in scheduling and facilitating site visits by external and internal monitors and auditors.
• Works with PI to evaluate research procedures; confers with PI to assist in developing plans for research projects; provides input of feasibility, cost, and workload in regards to participating in new clinical trials.
• Serves as a resource to clinical research staff, ensuring appropriate procedures and research projects are completed according to IRB and federal guidelines.
• May participate in the hiring, training, and evaluation of clinical research staff.
• Serves as a subject matter expert for clinical group and acts as a resource for protocol related questions.
• Facilitates communication with PIs to ensure that study objectives are met in a timely manner; maintains a cooperative relationship with Hematology/Oncology and other divisions and departments.
• Provides study coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols; consents participants for non-therapeutic clinical trials.
• Performs other duties incidental to the work described above.