Experience

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  Leidos

  • Clinical Research Associate

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  Leidos Biomedical Research, Inc.

  • Frederick, Maryland, United States

  • Clinical Research Associate

    • May 2018 - Present
    • Frederick, Maryland, United States

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  Johns Hopkins School of Medicine

  • Baltimore, Maryland Area

  • Clinical Research Associate

    • Jul 2015 - May 2018
    • Baltimore, Maryland Area

    CLINICAL RESEARCH ASSOCIATE Led site trainings during Site Initiation Visits and provided ongoing training as needed, prepared study start-up materials and tools. Monitored all phases of clinical trials and ensured Principal Investigator (PI) integrity and compliance with all protocol requirements. Performed source document verification (SDV) according to contractual requirements.  Ensured timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP). Completed and submitted visit reports according to Standard Operating Procedures (SOPs), Work Instructions (WIs) or Sponsor requirements, requiring minimal revisions.  Documented and tracked the resolution of all site-specific protocol-related issues from visit to visit.  Participate in the development, review and editing of Case Report Forms, Informed Consent Forms and study related documents Perform pre-study initiation, interim monitoring and close out visits as required Maintained regulatory documentation in adherence to Essential Regulatory Document Guidelines (EDRG) and Trial Master File (TMF) plan  Championed patient identification and recruitment plan while enforcing timely reporting of AEs/ SAEs and Protocol Violations. Regularly performed Investigational Product (IP) accountability and reviewed the status of contents of the site Regulatory Binder. Performed remote and risk-based monitoring to proactively identify possible issues and problems.

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  Johns Hopkins University

  • Baltimore, Maryland Area

  • Behavior Specialist/ Interventionist

    • Oct 2014 - Jul 2015
    • Baltimore, Maryland Area

    BEHAVIOR INTERVENTIONIST Conduct behavior interventions data collection activities in a busy HIV/STD clinic in compliance with the research protocols. Using motivational interview to assess study participants’ strengths as well as community barriers to care and correct as appropriate.  Develop, tailor, and disseminate educational materials and lesson plans for study specific intervention sessions.  Support and encourage study participants in self-care practices to include appropriate HIV care, medication adherence and substance use treatment. Completed session reports and resolved queries. Provide quality control and quality assurance of data recorded in CDMS and Electronic Medical Records

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  Battelle Memorial Institute

  • Baltimore, Maryland Area

  • Research Study Coordinator

    • Jan 2013 - Oct 2014
    • Baltimore, Maryland Area

    STUDY COORDINATOR Effectively screen and enroll participants into designated research study according to protocol Champion collaborative relationships with clinic and community partners, study staff, and sponsor  Collect and maintain accurate records of study activity including case report forms, drug dispensation records, or regulatory forms. Participate in the development of study protocols including guidelines for administration or data collection  Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Conduct data entry, abstraction, coding, evaluation and cleaning from electronic medical charts. Coordinate regularly scheduled staff meetings and conference calls. Performed quality analysis and control on all study related documents and equipment.Characterized, coded and evaluated related programs and policiesMaintained patient confidentiality by processing and storing research documents and updating and maintaining logs and filing cabinetsTraining and supervision of quality control staff

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  Medstar Union Memorial Hospital Cancer Program

  • Baltimore, Maryland Area

  • Intern

    • Jan 2012 - Sep 2012
    • Baltimore, Maryland Area

    •Participated in community outreach and health fairs in the Baltimore city area including planning meetings aimed at reducing the health disparities in Baltimore City. •Designed and presented a PowerPoint on lung, prostate, cervical and breast cancer, currently being used for education in underprivileged Baltimore City communities, with an emphasis on the importance of cancer screening. •Partnered with project managers in interviewing and recruiting individuals for routine cancer screenings at participating MedStar hospitals and for the Cancer Prevention Study-3, a new research study sponsored by the American Cancer Society •Created contacts with faith based organizations in underprivileged communities of Baltimore city in order to increase the target audience