The focus of the Sampson Lab at Boston Children's Hospital is to discover the molecular basis of nephrotic syndrome through human genomics to inform mechanisms, treatments, and cures for this disease. To help empower ourselves to do so, we recently established a biobank for pediatric kidney genomics - BIGKiDs ("Biobank to Illuminate the Genomics of Kidneys Disorders"). Through BIGKiDs, we will recruit eligible children from Boston Children's Hospital and other centers across the US and around the world. We will make genomic discoveries by pairing clinical information with genomic and molecular data generated from patient biosamples. To maximize its impact and accelerate its momentum towards discoveries, treatment, and cures, we now seek an enthusiastic, ambitious, and experienced Clinical Research Specialist to co-lead BIGKiDs with Matt Sampson, MD MSCE.
The Clinical Research Specialist II will be responsible for:
Leading the clinical research study process. Oversees collection, maintenance and retrieval of study data and implementing systems and procedures to ensure accuracy, consistency and conformance with protocol requirements.
Ensuring standards for data management and quality assurance are adhered to in each study.
Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned.
Coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. Corresponding with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
Recruiting study participants for enrollment in clinical trials. Following individual study protocols. Completing informed consent procedures. Organizing strategies for recruiting study participants, screening study participants for eligibility.
Organizing study procedures and scheduling study participants for study visits. Assisting the PI during patient visits. Performing study procedures designated for the Study Coordinator.
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.
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). Updating changes.
Collecting/processing study specimens, delivery to appropriate labs or packaging and shipping to appropriate facilities.
To qualify, you must have:
Bachelor's degree and 5 years of relevant experience OR MS and 2 year relevant work experience.
Analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data to solve problems.
Ability to communicate with parents/study participants to explain the research protocol, obtain informed consent, obtain accurate information from them, and provide them with accurate information.
Boston Children's Hospital offers a highly competitive compensation package with 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.
Internal Number: 3043183
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.