Clinical Research Assistant II- CDKL5 Program Job at Boston Children's Hospital
At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we’re committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included.
Under general supervision coordinates activities of daily operations of clinical research studies in the Rosamund Stone Zander Translational Neuroscience Center. Responsible for the screening, consenting, recruitment, and selection of patients for studies with a focus on rare neurodevelopmental disorders. Prepares IRB and/or CCI documentation and submissions in conjunction with the Principal Investigator and/or other members of the research team. Conducts data collection activities and prepares analytical reports regarding the results of studies. Assists in writing articles and summary papers for various publications.
This Clinical Research Assistant II will be responsible for:
- Assisting Principal Investigator (PI) in planning and implementing clinical research studies as assigned, including: liaising with study coordinators at other study sites in the natural history study to ensure compliance with recruitment goals and regulatory requirements across all study sites; coordinating preparation of protocol applications for submission to the IRB, study sponsor, regulatory authority, etc.; corresponding with the IRB, study sponsors, clinical research organizations, study participants, and referring physicians
- Recruiting study participants for enrollment in clinical studies, including organizing strategies for recruiting study participants, screening study participants for eligibility, and completing informed consent procedures
- Organizing study procedures and scheduling study participants for study visits. Assisting the PI during study visits
- Coordinating off-site visits, including travel arrangements; attending off-site visits
- Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms (CRFs); conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries
- Maintaining regulatory binders, case report forms, source documents, and other study documents; monitoring the occurrence of adverse events and reporting to the PI, the study sponsor and the IRB, if any
- Under the supervision of the PI, work with study staff to prepare for monitoring and audits by independent monitors, sponsors, and other regulatory agencies
- Collection or processing of study specimens, delivery to appropriate labs or packaging and shipping to appropriate facilities
- Assisting PI and other study staff with conference presentations and manuscripts by extracting and compiling data from investigator-initiated studies
- This position may offer candidates an opportunity to shadow physicians and other healthcare providers in an academic medical center
To qualify, you must have:
- A Bachelor’s degree from an accredited 4-year college or university with a major in the sciences, engineering, mathematics, or psychology
- Strong quantitative and analytical skills; comfortable with numbers
- Excellent interpersonal as well as oral and written communication skills
- Willingness to work flexible hours, as and when required
- A minimum of 1 year of experience as a clinical research assistant or equivalent is required
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. Experience the benefits of passion and teamwork.
Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.
Boston Children’s Hospital requires all employees to be vaccinated against COVID-19 and Flu, (unless you are eligible for a medical or religious exemption).
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.
Status
Full-Time
Standard Hours per Week
40
Job Category
Research
Regular, Temporary, Per Diem
Regular
Office/Site Location
Boston
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