Experience

Twill

• United States
• Mental Health Care
• 100 - 200 Employee

• Senior Clinical Trial Coordinator

  • May 2021 - Present

  Support Clinical Operations component of the Clinical R&D team by developing and implementing decentralized research studies in collaboration with internal stakeholders and pharmaceutical partnersDuties PerformedWrite, submit and revise IRB applicationsRun and manage all aspects of digital, decentralized studies with participants in specific therapeutic areasSubmit internal studies for Clinical Committee review and incorporate feedbackMonitor enrollment and retention in studies, and adapt recruitment strategies as neededProvide weekly project updates to Clinical R&D teamRespond to inquiries from potential and current participantsCreate and maintain entries in clinicaltrials.govRegularly interact with high-level internal and external stakeholders to coordinate the accomplishment of business needsPlan, coordinate, and arrange study communications and critical meetings with both internal and external attendeesSet up, maintain and close Trial Master Files; assure currency and accuracy of required clinical trials documents (i.e. CVs, Medical Licenses, Financial Disclosures, Investigator Agreements, etc.)Generate and revise study documents/communications as neededCreate and update internal SOPs



Chesapeake Urology Research Associates

• QA Research Compliance Officer

  • Aug 2020 - May 2021

  Duties Performed:o Assess research operations to evaluate and determine compliance risko Review, update and when applicable create standard operating procedures and guidelines for research officeso Create a site specific FDA management plano Continuation of training and preparations for FDA inspectionso Conduct internal monitoring review of research staffo Conduct regulatory review of all established studieso Prepare for Sponsor-initiated auditso Provide advice on corrective action for non-compliance with internal research policies and procedureso Assist with internal auditso Complete onboarding of new hires

• Senior Clinical Research Coordinator

  • Mar 2019 - Aug 2020

  Duties Performed:o Maintain research coordinator responsibilities while assuming a leadership roleo Provide guidance as needed to a team of study coordinators o Take initiative in improving workflow with third party vendorso Assist with onboarding new staffo Manage research assistants’ schedules

• Clinical Research Coordinator

  • Feb 2017 - Mar 2019

  Duties Performed:o Complete feasibility assessments for upcoming trials o Develop and implement strategies for participant recruitment and retention o Screen participants for eligibility via chart review, telephone and in-person interviewso Guide participants through informed consent processo Maintain source documentation, IRB documents, study logs, signed Informed Consent Forms, and study-related communicationso Ensure compliance with protocol, regulatory requirements and SOPso Facilitate routine monitoring visits, as well as site qualification, initiation, and closeout visits o Collect, handle, and ship biospecimens in accordance with laboratory manuals and IATA guidelineso Complete EDC entry and query resolutiono Maintain open communication with physicians, office staff, and research staffo Document protocol exemptions and deviations as appropriateo Schedule subjects for follow up visits, assess subjects’ response to therapy and evaluate for adverse eventso Review laboratory data and communicate abnormal lab values to PI/SI and primary care provider as neededo Administer study drug therapy as needed and maintain study drug inventoryo Report all SAEs and AEs to PI, sponsor, and IRB per protocol; subject’s primary care physician as needed

• Research Liaison/Recruiter, Floating Coordinator

  • Nov 2015 - Feb 2017

  Duties Performed:o Develop and update recruitment tools to encourage physician referrals o Network within the practice to spread awareness of clinical trialso Collaborate with marketing team to produce research advertisements and educational materialo Participate in community outreach events o Meet with local oncologists to discuss available trials for prostate and bladder cancero Conduct chart reviews within EMR system to locate eligible research patientso Perform study coordinator duties as needed to assist colleagues or to cover during extended leaves of absence



The Johns Hopkins University

• United States
• Higher Education
• 700 & Above Employee

• Research Program Coordinator

  • Jul 2013 - Oct 2015

  As a research coordinator at JHU's Behavior Pharmacology Research Unit, I coordinated and ran experimental research sessions for pharmacological research studies under the supervision of post-doctoral researchers, Ph.D., and M.D. investigators. I also processed data in accordance with research protocols. As a research coordinator at JHU's Behavior Pharmacology Research Unit, I coordinated and ran experimental research sessions for pharmacological research studies under the supervision of post-doctoral researchers, Ph.D., and M.D. investigators. I also processed data in accordance with research protocols.