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 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.
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. 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.
Organizing study procedures using GCP, and scheduling study participants. 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 policies and government regulations pertaining to human subjects protections.
Monitoring and auditing of the independent monitor, sponsor and 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.
The candidate will work under the supervision of the Clinical Research RN/Program Manager and faculty to manage and organize the operation of clinical research projects within established protocols. This position also serves as a liaison between the study coordinating center and other sites, and will assist the PI's and PM's in the selection, training, supervision and evaluation of support personnel.
To qualify you must have:
The knowledge of theories, principles, and concepts typically acquired through completion of a Bachelor's degree in a Health-related field, Biostatistics or Epidemiology, plus a minimum of two years of experience in research and regulatory oversight.
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 welldeveloped writing skills.
Boston Children's Hospital offers competitive compensation and unmatched benefits, including a flexible schedule, affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, cell phone plan discounts 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.
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.