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Clinical Research Specialist I
3 weeks ago
This Research Specialist will support clinical research in rare genetic conditions by facilitating online enrollment, online, remote and in person data collection, collection of medical records, and collection of biospecimens from patients around the world with rare genetic conditions we study in Wendy Chung's lab. Collection and analysis of these data will help us characterize these new genetic conditions and design clinical trials to test new treatments and interventions to treat these conditions. These rare genetic conditions include conditions that affect neurodevelopment, behavior including autism, structural congenital anomalies, pulmonary hypertension, and cardiomyopathies. The research coordinator will work with a team of physicians, scientists, genetic counselors, and nurses working together with rare diseases patient advocacy groups to better understand these rare genetic conditions.
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 and 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.
- Bachelor's Degree in STEM or Psychology, Master's preferred
- Three years of relevant work experience OR Master's and one year of relevant work experience.
- 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.
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Clinical Research Coordinator I
2 months ago
Boston, United States DM Clinical Research Full timeJob DescriptionJob DescriptionClinical Research Coordinator IThe CRC I will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds...
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Clinical Research Specialist I
1 day ago
Boston, United States Boston Children's Hospital Full time75356BR - Medicine-Genetics **Job Posting Description** - This Research Specialist will support clinical research in rare genetic conditions by facilitating online enrollment, online, remote and in person data collection, collection of medical records, and collection of biospecimens from patients around the world with rare genetic conditions we study in...
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Clinical Research Specialist I
1 week ago
Boston, United States Boston Children's Hospital Full timeThis Clinical Research Specialist I will be responsible for:Assisting Principal Investigators in planning and implementing clinical research studies as assigned. Under the direction of the PI, coordinating preparation of protocol applications for submission to the IRB, sponsor, or regulatory authority. As directed by the PI, corresponding with the IRB, study...
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Clinical Research Specialist I
4 weeks ago
Boston, United States Boston Children's Hospital Full timeThis Clinical Research Specialist I will be responsible for:Assisting Principal Investigators in planning and implementing clinical research studies as assigned. Under the direction of the PI, coordinating preparation of protocol applications for submission to the IRB, sponsor, or regulatory authority. As directed by the PI, corresponding with the IRB, study...
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Clinical Research Specialist I-Urology
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Clinical Research Specialist I
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Clinical Research Specialist I
1 month ago
Boston, United States Boston Childrens Hospital Full timeJob Posting DescriptionThe Digital Wellness Lab of the Division of Adolescent/Young Adult Medicine at Boston Children's Hospital, a teaching hospital of Harvard Medical School and the top-rated pediatric hospital in the nation, is seeking a skilled clinical research specialist for a full-time hybrid position. The Digital Wellness Lab is a nonprofit research...
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Clinical Research Assistant I, LZ, Hybrid
1 week ago
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