Scheduled Hours

40

Position Summary

Position 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; responsible for assisting in budgetary reports and ensuring billing and regulatory compliance standards are maintained; may supervise clinical research staff.

Job Description

Primary Duties & Responsibilities:

• 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; provides high level of direct and indirect support.
• 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 explains policies and procedures.
• Ensures that research projects are completed according to IRB and federal guidelines.
• Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; 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; researches and recommends new methods and procedures to maintain standards and improve quality.
• 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.

CONTACTS:

• Internal – Standard clinical research interactive relationships involved; work in close relationship with physicians, nurses, research coordinators, other staff, pharmacists, and laboratory personnel; work with other office personnel in data compilation; act as a liaison between the Hematology/Oncology Division and other divisions in regards to acquiring patient data.
• External – Interaction with research administrator, clinical staff and PI, testing/lab departments, clinical research organizations, and pharmaceutical companies.

Working Conditions:

Job Location/Working Conditions:

• Normal office environment.
   

Physical Effort:

• Typically sitting at a desk or table.
   

Equipment:

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

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

Certifications/Professional Licenses:

The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.

Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience:

Clinical Research (3 Years)

Skills:

Supervision

Driver's License:

A driver's license is not required for this position.

More About This Job

Required Qualifications:

• Basic Life Support certification must be obtained within one month of hire date.
• Basic Life Support ce