Passionate Clinical Research professional with strong history of meeting Sponsor and Research Site goals through implementing consistent and organized compliance practices. Skilled in meeting fast-paced deadlines and adapting to new challenges to best enhance the efficacy of the trial and research subject experience. I bring three years of expertise in coordinating all aspects of phase II and III clinical human imaging studies, including but not limited to study start-up and close-out, creating regulatory documents, overseeing implementation of protocols, and managing study data.
Overview
3
3
years of professional experience
4
4
years of post-secondary education
Work History
Clinical Research Coordinator II
Massachusetts General Hospital Research Center
Charlestown, MA
06.2019 - 05.2022
Significantly increased subject recruitment and retention from 4 per month to 10 per month by building mutually beneficial working relations with MGH physicians for referrals and with Site staff for more frequent scan slots.
Successfully recruited, screened, enrolled, and closed-out ~300 participants across multiple imaging studies within 3 years.
Ensured the quality, consistency and compliance of simultaneous research protocols while meeting the expected deadlines of our partnering Surgeons and Oncologists so they could promptly tailor disease treatment.
Conducted medical history screenings, informed consent interviews, and protocol-specific eligibility screenings, and study visits with research participants from multiple disease populations and across multiple departments.
Ensured subject’s physical safety and confidentiality through all steps of our trial and followed IRB and MGB guidelines on thoroughly and promptly reporting Adverse Events through the proper channels.
Managed and trained a small team of CRCs and college co-op interns in all aspects of implementing and maintaining a clinical trial, using the research scanner, and proper study participant interaction techniques.
Acted as primary point of contact between the lab and the IRB for all study document and start-up approval, amendments, annual reports, major deviations, and adverse events reporting.
Assisted the Co-PI in testing, troubleshooting, and streamlining a new data processing pipeline through learning basic Linux coding and field standards for reconstructing, co registering, and analyzing scan images for analysis.
Developed and implemented training documents, videos, and SOPs for incoming Lab employees to maintain adherence to all policies and procedures throughout the lifetime of the study.
Reviewed and organized all study generated data and regulatory documents to ensure quality, completeness, and compliance in general and in preparation for internal audit.
Education
Bachelor of Science - Neuroscience
University of Massachusetts Amherst
Amherst, MA
09.2015 - 05.2019
Skills
Good Clinical Practices
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Timeline
Clinical Research Coordinator II
Massachusetts General Hospital Research Center
06.2019 - 05.2022
Bachelor of Science - Neuroscience
University of Massachusetts Amherst
09.2015 - 05.2019
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