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Accomplished and innovative clinical operations professional with over 15 years experience managing complex clinical trials. Expertise in patient-focused global study management, with in-depth knowledge of ICH GCP guidelines, regulatory requirements, and site management. A creative problem-solver and effective collaborator, adept at working with diverse, cross-functional teams to drive success.
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Associate Director, Clinical OperationsKynexis Oct 2024 - Present -
Associate Director Clinical OperationsKaruna Therapeutics Feb 2023 - Jun 2024Boston, Massachusetts, Us -
Senior Clinical Project ManagerKaruna Therapeutics Jul 2021 - Jan 2023Boston, Massachusetts, Us
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Clinical Project ManagerKaruna Therapeutics Apr 2021 - Jul 2021Boston, Massachusetts, Us
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Associate Clinical Project ManagerKaruna Therapeutics Jul 2020 - Apr 2021Boston, Massachusetts, Us
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Associate Clinical Project ManagerProteostasis Therapeutics, Inc. (Pti) Aug 2019 - Jul 2020
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Senior Clinical Trial AssociateProteostasis Therapeutics, Inc. (Pti) Jun 2017 - Aug 2019
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Clinical Research AssociateQuintilesims May 2016 - May 2017Durham, North Carolina, Us• Perform site initiation, study-staff training, interim monitoring and close-out visits for multiple sites in accordance with SOPs and the trial master plan.• Motivate clinical investigators and site staff to achieve excellent protocol compliance and timely adverse event reporting.• Ensure study documentation is complete and properly maintained in accordance with the sponsor protocol, SOPs, ICH GCP guidelines, and FDA regulations.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation. -
Clinical Research Project ManagerMassachusetts General Hospital 2013 - 2016Boston, Ma, Us• Supervised team of Head & Neck Oncology study coordinators.• Managed clinical trial menu for disease group, assigned workload, and monitored and reassessed clinical trial priorities.• Scheduled and facilitated pre-site qualification visits, site initiation visits, and close-out visits for industry-sponsored trials.• Performed data analysis and QA/QC data checks for multi-site PI initiated trials.• Monitored affiliate site patient data; implemented procedures to ensure compliance.• Continued to manage a portfolio of trials; managing data and preparing regulatory submissions.• Managed new trial intake process and secured activation sign-offs from all participating departments.• Worked with sponsors to resolve any monitoring issues, provided current SOPs, and created standardized disease group notes to file when applicable. -
Senior Clinical Research AssociateMassachusetts General Hospital 2004 - 2013Boston, Ma, Us• Successfully managed several industry (all phases) and PI-initiated trials.• Prepared FDA and IRB submission of protocol revisions, safety reports, annual progress reports.• Ensured all pre-treatment screening and on-study assessments were in compliance with study-specific eligibility criteria, treatment guidelines, and federal, state, and institutional mandates.• Trained new staff and mentored junior staff.
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Clinical Research AssociateMassachusetts General Hospital 2002 - 2004Boston, Ma, Us● Collected, compiled and maintained protocol specific data for patients participating in clinical trials, and provided study-specific instructions to research coordinators and nurses to ensure protocol compliance and avoid deviations.
Allison Hughes Skills
Allison Hughes Education Details
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Harvard Graduate School Of EducationEducational Evaluation And Research -
Villanova UniversityPsychology
Frequently Asked Questions about Allison Hughes
What company does Allison Hughes work for?
Allison Hughes works for Kynexis
What is Allison Hughes's role at the current company?
Allison Hughes's current role is Associate Director, Clinical Operations.
What is Allison Hughes's email address?
Allison Hughes's email address is al****@****les.com
What schools did Allison Hughes attend?
Allison Hughes attended Harvard Graduate School Of Education, Villanova University.
What skills is Allison Hughes known for?
Allison Hughes has skills like Clinical Trials, Project Management, Clinical Research, Good Clinical Practice, Cross Functional Team Leadership, Data Management, Educational Research.
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