At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Division of Newborn Medicine department and discover how your talents can change lives. Yours included.
The Clinical Research Specialist I will be responsible for:
Overseeing collection, maintenance and retrieval of study data, and developing/implementing systems and procedures to ensure accuracy, consistency and conformance with protocol requirements.
Assisting study investigators in various study procedures, maintaining study documents and patient files, and completing Case Report Forms.
Assisting in planning and implementing clinical research studies as assigned. Coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority.
Overseeing and coordinating daily operations of studies. Completing follow up with study participants as required.
Organizing study procedures using GCP, and scheduling study participants for study visits. Assisting clinical team during study procedures.
Assisting in QC/QA reviews of current studies.
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms. Conducting periodic testing of data validity, identifying and resolving any errors or discrepancies.
Complying with all institutional policies and government regulations pertaining to human subjects protections.
Preparing for monitoring and auditing from external agencies including industry sponsors and the Food and Drug Administration (FDA).
Conducting the collection, processing and/or delivery of study specimens to appropriate labs or packaging and shipping to appropriate facilities. Creating and maintaining inventory of all research samples collected.
Providing guidance to less experienced staff and potential supervision of other staff members.
Ensuring work is performed in conformance with established hospital and program policies and procedures and all federal and state regulations.
To qualify, you must have:
Bachelor's degree in a health-related field, Biostatistics or Epidemiology and a minimum three years of relevant work experience or Masters of Science and one year of relevant work experience.
Experience working with industry sponsored trials preferred.
The analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data in order to solve problems OR design relatively complex systems and programs.
Communication skills in order to effectively deal with conflicting views or issues and mediate fair solutions, and well‑developed writing skills.
Boston Children's Hospital offers competitive compensation and unmatched benefits, including affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement and discounted rates on T-passes (50% off). Discover your best.
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.
Internal Number: 2787892
About Boston Children's Hospital
Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age.