Clinical Research Project Manager - Hematology Program

US Oncology is one of the nation´s largest health-care services network devoted exclusively to cancer treatment and research. Today, our network of over 1,200 affiliated physicians delivers care to more than half a million cancer patients each year.

SCOPE:
Responsible for the overall organization and administration of a clinical trial within the US Oncology Research network. Estimated scope of 180 office locations with 150+ employees working on a trial. The Project Manager is indirectly supervising the central staff as well as the field based staff working the clinical trial. Supervised by Manager, Research Programs. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Serves as the study point of contact for all clinical research staff. All questions related to the protocol, billing, payout, monitoring issues, etc. are directed to the project manager.
Modifies study tools (i.e. protocol specific flow sheets, clinical trial information sheets, and training documentation, etc.) to facilitate understanding of the clinical trial needs.
Training Facilitates ongoing project training throughout the trial timeline.
Reviews all monitoring and auditor follow-up letters as well as monitor survey forms for quality indicators. Works with the regional staff to facilitate quality improvement programs (i.e. plans of actions) related to clinical trials.
Prepares and coordinates central and site study specific pre-qualification visits, medical quality and FDA audits.
Reviews CRF tracking (data reports) to ensure that data is being completed timely from the field based staff. Review CRF tracking to ensure that US Oncology Research is being compensated for work completed. Contact clients for any issues regarding payment of services.
Review project status with the physician disease committee leadership. Provide the Study Investigator as well as the client, monthly operational reports.
Maintain working understanding of FDA and other regulations regarding the conduct of clinical research.

Job Requirements

EDUCATION:
BSN from an accredited school of Nursing or Bachelors degree in a Clinical or Scientific related discipline. Current license as a Registered Nurse in state of practice, if applicable. CCRC or CCRA certification preferred.

EXPERIENCE:
Minimum of 5 years related experience, including 3 years of clinical related experience. Prior oncology research experience required.

PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and use hands. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Requires vision and hearing corrected to normal ranges.

WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment and requires frequent interaction with corporate and field staff. Work may require travel by air or automobile approximately 10% of the time.

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