Clinical Research Specialist I-Center for Gender Health

Status

Full-Time

Standard Hours per Week

40

Job Posting Category

Research

Job Posting Description

Under minimum supervision, coordinates clinical research studies in the Center for Gender Health, a joint program with the Divisions of Endocrinology and Gynecology.  This work will support research in transgender health and will involve interactions with transgender youth, their families, and their medical records.

This Clinical Research Specialist I, will be responsible for: 

• Assists Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI coordinates preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. 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 trials. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants, screens study participants for eligibility on the telephone, in the clinic and other settings as required. Completes follow up with study participants in prescribed settings as required.
• Organizes study procedures and schedules study participants for study visits. Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
• 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. Completes data entry as warranted.
• Complies with all institutional policies and government regulations pertaining to human subjects 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 prepraration for journal publication. Performs literature searches and pulls articles.

To qualify, you must have: 

• A Bachelor’s Degree in STEM (Psychology, Social Sciences, Biological Sciences and Public Health) and a minimum of 3 years of work experience OR a Masters Degree and 1 year of work experience.
• Experience and interest in adolescent health, public health, psychology, sexual orientation and gender identity, epidemiology, and statistical methods preferred.
• Excellent verbal communication skills.
• Excellent writing skills essential.
• Ability to maintain participant data confidentiality and adhere to study protocol.
• Experience and comfort using: computer applications (Microsoft Office, PowerPoint, Excel, etc.) (essential), statistical software (SPSS for statistical analysis, etc.)(preferred) and website management tools (preferred).
• Ability to take initiative, work without direct supervision, multi-task, work on multiple projects with changing deadlines.
• Strong organizational and time-management skills.

Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. 

Office/Site Location

Boston

Regular, Temporary, Per Diem

Regular

Remote Eligibility

Part Remote/Hybrid