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Clinical Research Manager I

Brookline, MA, United States

Job Posting Description

The Hematology Clinical Research Group at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center is seeking a clinical research manager. Ground-breaking research within the group focuses on disorders of hemostasis and thrombosis, congenital and acquired anemias including sickle cell disease and thalassemia, immune cytopenias, and other non-malignant pediatric hematologic disorders. Research studies are investigator initiated and industry sponsored and range from observational studies and registries to biobanking to interventional clinical trials of novel treatments.

The Dana-Farber/Boston Children's Cancer and Blood Disorders Center has exceptional research and clinical programs in non-malignant hematology. The clinical service in non-malignant hematology includes a busy inpatient consult service, and approximately 5000 ambulatory visits per year, including about 1500 new patients annually.

This Clinical Research Manager I will be responsible for: Oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.

Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.

Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Budget offices.

Develops and oversees the implementation of best practice guidelines for conducting various clinical research protocols

Collaborates and consults with investigators and their staff on the design, development, and conduct of clinical research studies

Assists the principal investigator in preparing manuscripts for publication.

Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.

Leads design and development of data management and data monitoring tools and procedures and supervises data management staff and activities in compliance with GCP and program standards.

Leads and manages the work of multiple clinical research projects. Serves as Clinical Research Study / Trial Manager for one or more large, clinical studies.

Manages communication between study staff and internal and external stakeholders

Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.

Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.

Responsible for the recruitment and oversight of all the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.

Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.

In order to qualify, you must have: Bachelor's degree in STEM or Psychology, Master's degree preferred.

6 years' of relevant work experience or Master's degree and 4 years' relevant work experience.

Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.

Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.

Advanced writing skills.

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