Accomplished Clinical Research Associate with 5 years' experience in performing and documenting pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies in accordance with good clinical practices, study-specific requirements, clinical monitoring plans, company procedures, applicable regulatory requirements and defined quality standards. Clear communicator when working with internal teammates and external contacts.
Skills
6 years of clinical research associate.
Experience working in phases I-III clinical trials.
Adaptability to changing requirements.
Ability to perform up to 80% of nationwide travel.
Encompasses study management and GCP compliance, safety management (adverse event identification and reporting, post market surveillance, and pharmacovigilance), and handling of investigational product.
Encompasses all elements of communication within the site and between the site and sponsor, CRO and regulators, as well as the understanding of teamwork skills necessary for conducting a clinical trial.
5 years of oncology experience.
Experience working with top performing sites eg. MD Anderson, Dana Farber, MSKC, Princess Margaret etc.
Work History
Clinical Research Associate II, 01/2017 to Current Danaher – Paramus, NJ,
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
Involvement in the generation of project plans, especially those related to site management, monitoring and reporting.
Involved in the development of protocols and Case Report Forms (CRFs) as assigned.
Manages the identification, selection and feasibility processes.
Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensures the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitor for missing or implausible data.
Prepares accurate and timely trip reports.
Organizes and makes presentations at Investigator Meetings.
Interacts with internal groups to evaluate needs, resources and timelines.
Acts as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Clincial Research Associate I, 07/2014 to 01/2017 Cancer Treatment Centers Of America – Madison, WI,
Evaluated electronic data capturing systems for adherence to guidelines.
Conducted initiation, monitoring and closeout visits.
Checked drug storage procedures for compliance with protocols and SOP requirements.
Monitored collection, accuracy and integrity of regulatory documents in site binder.
Reviewed participant eligibility and documentation of consent.
Collected, evaluated and modeled collected data.
Monitored unit budget to ensure financial objectives were met.
Collected data and followed research protocols, operations manuals and case report form requirements.
Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols.
Followed informed consent processes and maintained records.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Clinical Research Coordinator, 01/2012 to 07/2014 Sheppard Pratt Health System – City, STATE,
Participated in interview selection and evaluation of other research staff.
Provided training and orientation to project.
Coordinated work schedule monitored adherence to procedures/protocols to ensure optimal patient participation rates accurate data collection timely follow up and the like.
Provided input into development of performance evaluation for non-clinical aspects of staff assigned to project.
Organized and implemented the protocol of the project provides direct services as outlined by the grant criteria.
Assisted in coordinating clinical research projects including regularly functioning as research assistant to perform related activities which included: review of records identification of patients meeting eligibility criteria establishing and maintaining research records for study participants review medical records to abstract information administer standardized tests and entering data into computerized database.
Assisted research investigators in budgeting and managing financial accounts effectively within the guidelines and policies established by the Hospital as well as sponsoring agencies.
Resolved problems and monitored monthly expense reports for accuracy and conformance to budget.
Coordinated collaborative work with other investigators and/or sites.
Maintained quality assurance in accordance with established hospital department policies and objectives.
Education
Bachelor of Science: Psychology , Expected in Chesapeake College - Wye Mills, GPA:
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