Clinical Research Specialist I

General Summary
The Hematology Clinical Research Group at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center is seeking a Clinical Research Assistant. 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.

Key Responsibilities

• Assisting Principal Investigators PIs in planning and implementing clinical research studies as assigned. Under the direction of the PI, coordinates preparation of protocol applications for submission to the IRB, sponsor, or regulatory authority. As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants, and referring physicians.
• Completing record abstraction of source documents, conducts required study measurements and completes study Case Report Forms in accordance with best practice methods.
• Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries. Completes data entry as warranted.
• Complying with all institutional policies and government regulations pertaining to human subjects' protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the PI, the study sponsor, and Committee on Clinical Investigations IRB. Updates protocol and amendment changes.
• Assisting investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles.

Minimum Qualifications
Education:

• Bachelor's degree, Master's preferred

Experience:

• Bachelor's degree with 3 years of relevant work experience OR Master's degree and 1 year of relevant work experience; Team also open to hiring Clinical Research Assistant II requiring a Bachelor's degree and 1 year of post undergraduate experience.
• Ability to make a 2-year commitment.
• 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.

Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.