Boston Children’s Hospital
Clinical Research Coordinator- The Neuromuscular Program
Boston Children’s Hospital, Boston, Massachusetts, us, 02298
Position Summary
The neuromuscular program is part of the Neurology Department at Boston Children's Hospital. Our team is comprised of 7 CRAs (Clinical Research Assistants) & CRCs (Clinical Research Coordinators) working under 4 researchers (Basil Darras, MD, Partha Ghosh, MD, Leslie Hayes, MD, and Regina Laine, NP) with over 30 ongoing clinical trials. Most trials are sponsor funded-investigational drug trials and involve patients with SMA (Spinal Muscular Atrophy), DMD (Duchenne Muscular Dystrophy). As a CRC, you would be responsible for facilitating and coordinating the trials on a day-to-day basis. Teamwork, organization, adaptability, and creativity are extremely important for any candidate. This position is looking for someone to start ASAP and a two year time commitment is preferred.
Key Responsibilities
Working with Principal Investigators (PIs) to facilitate and coordinate the everyday activities of assigned clinical trials including scheduling patient visits with many different departments e.g. Physical Therapy, Radiology, and Anesthesia.
Attending and organizing all study visits with the participant and family.
Monitoring for Adverse Events with study participants, and reporting them to the PI, IRB and sponsor in a timely manner.
Facilitating communication between the PI and the patients.
Maintaining study protocol documents for applications or amendments to the IRB.
Ensuring that all staff involved in the study have been trained properly.
Coordinating with study sponsors and monitors to ensure compliance with the protocol and reporting protocol deviations.
Maintenance of regulatory binders, Case Report Forms, Visit Order forms and other study related documentation. Ensuring patients are reimbursed for their visits.
Recruiting, screening and consenting patients to studies.
Data entry and resolution to data entry queries.
Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis.
May write articles and summaries of studies for submission.
May present study results at local and national meetings.
Mentoring CRA’s, residents, fellows in day to day of clinical research
Minimum Qualifications Education
A Bachelor's Degree is required.
Master's Degree is preferred.
Experience
2 years of relevant experience is required.
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Key Responsibilities
Working with Principal Investigators (PIs) to facilitate and coordinate the everyday activities of assigned clinical trials including scheduling patient visits with many different departments e.g. Physical Therapy, Radiology, and Anesthesia.
Attending and organizing all study visits with the participant and family.
Monitoring for Adverse Events with study participants, and reporting them to the PI, IRB and sponsor in a timely manner.
Facilitating communication between the PI and the patients.
Maintaining study protocol documents for applications or amendments to the IRB.
Ensuring that all staff involved in the study have been trained properly.
Coordinating with study sponsors and monitors to ensure compliance with the protocol and reporting protocol deviations.
Maintenance of regulatory binders, Case Report Forms, Visit Order forms and other study related documentation. Ensuring patients are reimbursed for their visits.
Recruiting, screening and consenting patients to studies.
Data entry and resolution to data entry queries.
Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis.
May write articles and summaries of studies for submission.
May present study results at local and national meetings.
Mentoring CRA’s, residents, fellows in day to day of clinical research
Minimum Qualifications Education
A Bachelor's Degree is required.
Master's Degree is preferred.
Experience
2 years of relevant experience is required.
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