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Work Background
ICON Strategic SolutionsProject Manager - Dedicated to Merck
Nov. 2021United StatesResponsibilities • Support multiple global clinical trials from Phase I to Phase IV, in Oncology and ID/Vaccines • Coordinate with cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs, to ensure seamless project execution. • Monitor trial progress, identify potential issues, and implement corrective actions to mitigate risks and ensure project milestones are met. • Foster strong relationships with key stakeholders, including investigators, site staff, and external vendors, to ensure effective communication and collaboration. • Maintain electronic Trial Master File (eTMF) in Veeva Vault system, ensuring accurate and up-to-date documentation throughout the trial lifecycle. • Create and maintain Excel documents for sample management and study enrollment, ensuring accurate tracking and reporting. • Conduct regular project status meetings and provide updates to senior management. • Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and FDA regulations. • Mentor and train junior staff, providing guidance and support to enhance team performance.
Memorial Sloan Kettering Cancer CenterRegulatory Research Project Manager
Sep. 2019 - Nov. 2021New York, New YorkResponsibilities • Supervised the training/development and performance management for all regulatory staff within service • Ensured that all appropriate institutional, state, and federal regulations are followed throughout the course of 150+ gastrointestinal (GI) oncology clinical trials • Participated in and ensured preparedness in 20+ internal audits for regulatory compliance and patient safety issues related to clinical trials • Oversaw corrective and preventative actions (CAPA) for 20+ internally audited trials until completion • Communicated and ensured compliance with company policies and procedures, quality standards, and improvement initiatives within the service • Initiated 30+ new protocol submissions at MSK, and oversaw the collection/development of essential study documents • Completed annual Investigational New Drug applications for all GI investigator-initiated trials Achievements • Collaborated with Institutional Review Board (IRB) to develop improved amendment and continuing review report submission processes • Selected to participate in IRB working group which improved process for all clinical research trials at MSK • Developed and reviewed study specific tools to streamline protocol laboratory orders, research blood collection, and confirm subject eligibility • Received rarely accorded “Exceeds Expectations” on 2020 Performance Review
Weill Cornell MedicineRegulatory Specialist - Hematology Oncology Clinical Trials
Feb. 2018 - Sep. 2019New York, New YorkResponsibilities • Directed and led all protocol activation for 40+ hematology and oncology studies ensuring patient focus, activation goals, and accountability • Collaborated/coordinated with all internal and external stakeholders on protocol areas to ensure rapid activation • Assessed complex protocols quickly and planned effective activation timelines • Managed all submissions to review committees, sponsors, clinical research administration units, and clinical departments per institutional guidelines to meet time to activation expectations while ensuring high quality • Ensured maintenance of up-to-date regulatory records and compliance with industry deadlines for over 80 research projects • Coordinated amendment and continuing review submissions for over 80 research projects • Prepared and submitted all regulatory documents to sponsor and/or contract research organization (CRO) • Wrote informed consent documents and converted model consents to WCM template. Achievements • Negotiated consent language with external industrial sponsors, ensuring that sponsors understood expectations of WCM’s IRB and utilization of WCM standard text • Maintained and disseminated accurate listings of active and potential studies to participating investigators • Served as the main resource for detailed information on assigned protocols and other investigational research activities • In addition to genitourinary trials’ responsibilities, recruited to complete regulatory tasks for other services within the Department of Hematology and Oncology, including leukemia and lymphoma • As one of the more senior and experienced Regulatory Specialists, I was selected to train and mentor new staff members • Created study maintenance trackers in Excel, which became the new tracking standard for institution-wide research projects
Memorial Sloan Kettering Cancer Center / Department of Hematology/OncologyResearch Study Assistant II
Jun. 2015 - Feb. 2018Greater New York City AreaResponsibilities • Efficiently and accurately perform data collection/reporting/quality assurance/regulatory compliance for complex data and sample intensive Phase I, II, & III sponsored leukemia clinical trials • Schedule patient assessments/data collection for 40 patients within protocol windows • Comply with all FDA regulations/CFR/ICH/GCP/MSK SOP/IRB protocols/Report SAEs/external safety events • Maintain investigator site files at MSK/participate in site initiation and interim monitor visits • Confirm training is recorded from site initiation of a protocol/amendments/addition of new investigators • Ensure quality and integrity of data/resolve sponsor queries/troubleshoot/solve problems/self-audit •Collect/store/ship bio specimen samples/certified shipper of dangerous goods Major Achievements • Enrolled 15 of 30 participants in Phase I data intensive study/six in a Phase II study/one in Phase III study • Single-handedly significantly reduced inherited Phase I protocol violations/eliminated backlog of 300 queries • Developed patient data trackers to coordinate medications/adverse events/medical history/medication sources and streamline process/implemented service standards to reduce deviations • Prepared for two sponsor audits/assisted in preparation for FDA audit/reviewed databases/updated information • Met every sponsor data deadline because of hard work/initiative/skilled analysis/creative problem solving • At sponsor’s invitation, presented at Investigator Meeting on data collection and preparing for a data base lock • Collaborated with clinical session assistants on timely research assessments/distribution of research kits/patient scheduling, resulting in far fewer scheduling problems and smoother patient visits • Developed positive working relationships/effective communications with research/clinical/monitor teams • Served as a preceptor to RSA I Technology/Skills • EMR systems/CTMS systems/Medidata/Inform/Datatrak/Vestigo/Microsoft Office
Boylston Place Of Chestnut Hill An Epoch Assisted Living FacilityAdministration/Marketing and Sales/Human Resources Intern
May. 2014 - Jul. 2014Greater Boston Area• Created a company-wide knowledge base/calendars using Microsoft Word and Excel documents • Assisted with organization of, and participated in, major onsite marketing event, supported sales and marketing staff at senior center event, promoted facility to prospective residents, prepared marketing materials • Organized residents’ medical records for state audits • Planned employee trainings on patient care, organized human resources records, reviewed employee credentials
College of Health and Human DevelopmentWomen's Leadership Initiative
Aug. 2013 - May. 2014University Park, PA• Selected from large pool of applicants to be among 30 participants based on GPA and leadership potential • Led panel discussion in state capital with court justices • Participated in leadership development activities, team building, problem solving exercises
Vector MarketingRecruiter, Recipient of Presidential Award for Excellence in Recruiting
May. 2012 - Aug. 2012Greater New York City Area• Recruited sales team, handled telephone/email inquiries, promoted company to potential hires • Evaluated candidate’s basic qualifications, scheduled and conducted interviews • Assisted with management of sales team, coordinated training sessions, resolved scheduling issues
Brent W. Spears, M.D. P.C.Medical Biller / Electronic Health Records (EHR) Coordinator (Part-time)
Jan. 2012 - Dec. 2014Farmingville, New York• Processed medical claims using Kareo system to prepare, ICD-9 code, and submit physician bills to Medicare • Analyzed/resolved coding/billing discrepancies/created Excel spreadsheets to track claim progress • Participated in conversion of paper to Practice Fusion EHRs for multistate physician practice group • Implemented EHRs, coordinated EHRs with Kareo system for coding/reimbursement, performed data input
Office of Undergraduate Admissions Volunteer, Penn StateVolunteer Tour Guide, Ambassador for CIVSA Conference, 2014 Tour Guide of the Year, S.M.A.RT Liaison
Sep. 2011 - May. 2015University Park, PA• Conducted campus tours and led panel discussions for prospective students and their families • Selected to participate in prestigious Penn State football recruiting program, attended games/events with prospective players and their families, interfaced with coach/players, promoted Penn State • Appeared in professionally produced admissions marketing/recruitment YouTube videos • Interviewed candidates for the Executive Director of Undergraduate Admissions position • Presentation to Collegiate Information & Visitor Services Association (CIVSA) conference on the import of teamwork between the admissions office and student organizations in planning/execution of recruitment events
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