Senior Clinical Research Coordinator - Pediatrics Hematology & Oncology

Overview

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.

• 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.

• 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.

Job Location /

Working Conditions:

Normal office environment.

Physical Effort:
Typically sitting at a desk or table.

Equipment:
Office equipment.

Required Qualifications:
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.

• 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).

• SoCRA or ACRP certification.
• Experience in Pediatrics and/or Oncology.
• Experience with pharmaceutical sponsored therapeutic protocols.

Preferred Qualifications:

Master s degree

Certifications / Professional Licenses:
No additional certification/professional licenses unless stated elsewhere in the job posting.

Work Experience:

No additional work experience unless stated elsewhere in the job posting.

Skills:

Clinical…