Results focused Clinical Research Associate with demonstrated attention to detail, extensive knowledge in various therapeutic areas such as Neurology, Oncology, Cardiovascular, Reproductive Health, Endocrinology, and Gastroenterology. Experienced in managing multiple trials simultaneously, communicating/negotiating with study vendors, prioritizing workload to successfully accomplish study timelines and milestones, and providing assistance to colleagues and site staff as needed.·
Skills
Manage clinical research trials and vendor relations for the conduct and execution of clinical trials.
Maintain study start-up through site/study closure for assigned trials.
Manage EDC data review through query to resolution.
Project Management activities through effectively motivating & leading project team members, delegating tasks as necessary.
Manage the workload of self and others in relation to study timelines by prioritizing and delegating work.
Experience
10/2015 to Current
Clinical Site Manager IIPlanet Pharma – Quakertown, PA,
Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close Out of the trial.
Oversees conduct of trial at designated sites to ensure rights and well-being of subjects are protected.
Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements.
Conducts Remote Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generates contact and site visit reports in compliance with the monitoring plan.
Reviews site recruitment plans and takes action to drive recruitment in collaboration with the site staff on an ongoing basis.
Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other and study specific procedures, plans and training.
Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.
Uses site management experience and understanding of clinical trials methodology to demonstrate leadership and problem solving.
Perform regular reviews of site level data (e.g. CTMS, EDC, IVRS, and ISIS) and ensure timely and high quality data entry compliance from sites.
Ensure good understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely and efficient delivery.
Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files as per Central File Maintenance Plan.
05/2015 to 09/2015
Clinical Trial AssociateAccentcare – Marble Falls, TX,
Support operational aspects of Global Clinical Operations (GCO) managed clinical trials.
Support trial management activities across the various phases of a trial (start-up, execution and closeout).
Responsible for setting up meetings and maintaining minutes.
Assist GTM in management of study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.
Manage CTMS with expectations that study status is available at all times; work with local Affiliates.
Ensure trial specific data are up-to-date, complete, accurate and consistent.
Manage eTMF (Central Administrative File) across various phases of a trial.
Support team-specific Sharepoint sites to ensure availability of all central trial documents.
Ensures investigator/IRB lists are available for Clinical Study Reports.
Liaise with Contract Research Organization/Academic Research Organization teams if outsourced trial and as defined by GTM.
11/2013 to 05/2015
Clinical Support SpecialistPra Health Sciences – Boston, MA,
Provide Clinical Support on various Oncology & Cardiovascular trials including Breast Cancer, Melanoma, Leukemia, Rare Cancers, Renal Cell Carcinoma & Type II Diabetes.
Maintain Clinical Investigator, Site, & Vendor relationships on multiple study projects (Phases I-IV) via strong communication and interpersonal skills.
Participate in Investigator Meetings, Site Trainings and Weekly Team Meetings.
Mentor & train study team(s) on clinical study systems, process & best practices.
Oversee site contracts and budgets to ensure accuracy within study guidelines & parameters.
Manage clinical trial activities according to operating standards and good clinical practice and meet or exceed customer expectations on time and within budget.
Track SAE reporting from study sites to make sure they are submitted within the specified timeframe.
Maintain quality of data in study systems such as e-track (CTMS), eDX, and TMF to ensure accurate and timely planning, monitoring, execution and reporting of clinical studies.
Maintain timely & consistent communication with sites regarding study documents & updates.
Assist in development of study specific processes, procedures & resourcing needs for clinical studies and oversee that established timelines, milestones & study objectives are met.
Monitor site status regarding patient recruitment & retention of patients in clinical studies.
Participate in file audits in order to maintain current site data and documents.
Provide support as needed with changes to Site Monitoring Plan, Protocol Amendments, & ICFs.
Apply knowledge of GSK’s processes and procedures, SOPs and ICH guidelines in conduct of clinical trial.
Maintain quality of data in study systems (e-track, eDX, IMMS TMF) to ensure accurate and timely planning, monitoring, execution and reporting of clinical studies.
Review and track study invoices including resolution of investigator grant payments, invoice accuracy comparison to contract and outstanding payments.
Support multiple studies simultaneously and prioritize appropriately to meet business needs to ensure delivery of results.
Proactively summarize information from systems to support studies, including the development of complex/innovative information management solutions and systems.
03/2010 to 10/2013
Site Management AssociatePRA Health Sciences Inc. – City, STATE,
Recruited and evaluated Late Phase clinical study sites through active communications with Physicians and Study Coordinators.
Conducted critical document assembly for review, maintenance and close out activities.
Maintained communication with study sites for EDC & Protocol Trainings, Site Initiation Visits and Close Out Visits.
Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines.
Supported investigators with submissions insuring local, regulatory, and IRB/IEC requirements are met.
Managed clinical study information in Clinical Trial Management System (CTMS).
Liaised with internal and external customers to make certain the achievement of project specific goals
are met.
Participated with sponsor and project-related meetings interfacing with both client and team. Tracked patient enrollment, necessary supplies, and data entry for assigned study sites.
Supported Coordinator and Investigators with protocol guidance, study related tasks, and electronic systems.
Reviewed clinical data for enrolled patients and data discrepancies within clinical databases.
Created queries related to the CRF/eCRF data (DCF - Data Clarification Forms)
Mentored and trained new site management staff with PRA and/or study related systems and tasks.
Implemented and monitored post-marketing studies to ensure sponsor and investigator obligations are met.
Education and Training
Expected in 06/2009
Web Design Certification: The Art Institute of Pittsburgh - Pittsburgh, PA, GPA:
Expected in 05/1998
Bachelor of Science: Hotel, Restaurant, & Tourism Management East Stroudsburg University of Pennsylvania - East Stroudsburg, PA GPA:
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