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 Pulmonary Medicine and discover how your talents can change lives. Yours included.
The Clinical Research Specialist II will be responsible for:
Assisting Principal Investigators (PIs) in planning and implementing clinical research studies and quality improvement initiatives as assigned. Coordinates the preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. Corresponds with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
The coordination of preparation activities and for the daily operations of clinical research studies
Serving as liaison with the study management center and other participating sites
Preparing IRB and CCI documentation and submissions in conjunction with the Principal Investigator
Creating informed consent templates and editing consent drafts in collaboration with Study PIs for multi-site studies.
Recruiting study participants for enrollment in research studies. Following individual study protocols. Completing informed consent procedures as assigned. Organizing strategies for recruiting study participants, screens study participants for eligibility on the telephone, in the clinic and other settings as required. Completing follow up with study participants in prescribed settings as required.
Organizing study procedures and scheduling study participants for study visits. Assisting the PI during patient visits.
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.
Complying with all institutional policies and government regulations pertaining to human subjects protections. Maintaining regulatory binders, case report forms, source documents, and other study documents. Monitoring the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB).
Working with study staff to prepare for monitoring and audits of the independent monitor, sponsor and Food and Drug Administration (FDA).
Assisting investigators in investigator initiated clinical research protocols. Performing literature searches. Attending applicable courses and meetings.
Contributing to teamwork within and between departments, divisions, programs and other organizations.
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:
The knowledge of theories, principles, and concepts acquired through completion of a Bachelor's degree and a minimum of 5 years of relevant experience or Masters of Science and 2 yrs relevant work experience.
The 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. Work also requires advanced writing skills.
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.