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Job Descriptions:

New England Cancer Specialists (NECS) is seeking a fulltime Research Clinical Program Manager in our Westbrook practice. The Research Program Manager role is designed to lead research initiatives. The employee will work within a dedicated Research Department in an outpatient setting to provide administrative operational and project management support. This detail-oriented, self-starting individual will work closely with internal colleagues, as well as external collaborators (Academic Institutions, Network Partners, Industry Sponsors, CROs) to support the development of the research program at NECS. In this role the employee will oversee pre- and post-award study management activities and support the Research Director in the day-to-day operational aspects of assigned projects to ensure compliance with local, state, and federal research regulations.

NECS is a private medical practice composed of 18 oncologists and hematologists serving the region from four separate locations in Maine and New Hampshire. Our mission is to make life better for people with cancer and blood disorders. Kindness, compassion, and respect are part of everything that we do - from our phone operators to our physicians, every person on our team is important, and everyone makes a difference every day. We are proud to be the first Dana Farber Affiliate practice in the country, striving to provide the highest quality care and unmatched, holistic support for every patient, every day.

Job Duties:

+ Provide support in the development and management of Phase I, Radiotheranostics, and Bispecific programs

+ Review of project budgets and associated contracts to assure compliance with policies, including managing vendors to ensure they adhere to the agreed upon contract parameters

+ Responsible to report on defined deliverables, to identify variances in project plan and to develop contingency plans when necessary to keep project milestones on track

+ Ensure relationships with network groups and staff, study quality management, personnel management and career skill development, regulatory compliance, and fiscal oversight

+ Track and assess study metrics to aid in departmental process improvement and SOP development

+ Ensure clinical activities are performed in accordance with the protocol and within clinical procedure safety standards

+ Ensure confidentiality of patient records and data: HIPAA compliance

+ Assist in the start-up, maintenance, and close-out of clinical trials

+ Provide support in the development of Medicare Coverage Analysis, study budgets/negotiations, billing compliance, and study financials over the life of the study

+ Identify and evaluate risks, interpret data on complex issues, and implement solutions in order to ensure successful completion of clinical trials

+ Serve as a mentor and colleague to follow research staff

+ Performs miscellaneous, job-related activities as assigned

Required Experience:

+ Bachelor’s Degree and work experience as a Clinical Research Coordinator or Research Project Manager.

+ A minimum of 5-10 years of work experience with clinical trials, or a combination of clinical trials and relevant work experience required

+ Contract and vendor management experience

+ Knowledge and experience applying Good Clinical Practice (GCP) and ICH Guidelines

+ CITI certification preferred. Must be able to complete CITI program upon hire.

+ Research Coordinator/Project Manager certification (ACRP CCRC-PM) preferred. Expected to attain certification when eligible.

+ Oncology experience preferred.

Keyword: Clinical Research Coordinator, trials, research

From: New England Cancer Specialists