Clinical Research Specialist Per Diem - Boston Children's Hospital

Boston Children's Hospitals Department of Psychiatry is looking for a Clinical Research Specialist/Coordinator to conduct neurodevelopmental assessments for research studies on a part-time basis of 1-2 days/week. 

The candidate must have minimum qualifications of:

• A Bachelors in Psychology, Child Development or Allied Field with 3 years of relatable experience or a Master’s degree in Psychology, Child Development or Allied Field with 1 year of relatable experience.
• Prior experience administering developmental assessments such as the Bayley Scales of Infant and Toddler Development.

Principal Duties & Responsibilities

• 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 preparation for journal publication.
• Performs literature searches and pulls articles. Participates in writing articles and summary papers for various publications. 

Knowledge, Skills and Abilities

• 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.
• Advanced writing skills.

Benefits
Consistent with our belief that our employees are our most valuable resource, Boston Children’s Hospital offers a competitive and inclusive benefits package.