Boston, Massachusetts

Job Posting Description

At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we are committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included.

The Clinical Research Specialist Responsibilities:
  • Under the direction of the PI and Program Manager coordinates preparation of protocol applications for submission to the IRB and manages site IRB-related issues, and site-related sponsor or regulatory authority issues (CDC, NIH).
  • As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
  • Recruits study participants for enrollment in clinical studies.
  • Completes informed consent procedures as assigned.
  • Organizes strategies for recruiting study participants, screens study participants for eligibility using data in the clinical chart and from bedside providers.
  • Completes follow up with study participants in prescribed settings as required.
  • Organizes study procedures and schedules study participants for enrolled patients.
  • Assists the PI during patient enrollment and follow up.
  • Assists the Program Manager and PI in multicenter study activities. These include data cleaning, confirmation of data completion, site invoice approval tracking submission, development of training materials, and scheduling of meetings.
  • Completes 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.
  • Complies with all institutional policies and government regulations pertaining to human subject’s 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.
  • Assists investigators in data and/or document preparation for journal publication.
  • Performs literature searches and pulls articles. 
  • Evaluates data from REDCap database extractions and develops figures and tables for publications.

Minimum Education and Experience

  • Bachelor's degree, and a minimum three years of relevant work experience (two years post-Bachelor’s degree) or Masters of Science and one year of relevant post-Bachelor’s degree work experience.

Knowledge, Skills, and Abilities

  • 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.

Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.

Boston Children’s Hospital offers competitive compensation and unmatched benefits.
 
Boston Children’s Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.

 

Boston, Massachusetts

Boston Children's Hospital is a 404-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Boston Children's offers a complete range of health care services for children from birth through 21 years of age. (Our services can begin interventions at 15 weeks gestation and in some situations we also treat adults.)

We have approximately 25,000 inpatient admissions each year and our 200+ specialized clinical programs schedule 557,000 visits annually. Last year, the hospital performed more than 26,500 surgical procedures and 214,000 radiological examinations.

Our team of physicians and nurses has been recognized by a number of independent organizations for overall excellence, and we're proud to share some notable examples with you here.

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