Clinical Research Manager I

2 weeks ago

Brookline, United States Boston Childrens Hospital Full time
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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