LiveCareer-Resume

senior cra lead cra resume example with 8+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Summary

An experienced Clinical Research professional well-versed in study protocols, standard operating procedures, and general trial oversight looking to associate myself with an organization to prove my innovative skills and to work in a position where my skills and knowledge are utilized in the best possible way, which provides me with an opportunity for growth in my professional career and also contributes to the growth of the organization.

Summary of Experience:

  • Thorough knowledge of relevant regulations (ICH-GCP guidelines, FDA Regulations)
  • CAPA Resolution and Management of Audits finding Good working knowledge of systems used in clinical trials
  • Training and mentorship to junior CRAs
  • Phase I, II and III clinical trials experiences
  • Effective at communicating and providing guidance to clinical trial site
  • Therapeutic Experience includes:

Cardiovascular | Hypertension | Pulmonary Arterial | Myocardial Infarction | Phase II and III

Vaccine |Influenza |Phase II and III

CNS | Myasthenia Gravis | Narcolepsy | Borderline Personality Disorder | Schizophrenia | Parkinson's Disease| Phase II and III

Ophthalmology | Glaucoma | Phase II

Medical Device | Class II

Psychiatry | Depression | Phase III

Oncology | Metastatic Solid Tumor| Metastatic Solid Tumor|Osteosarcoma| Phase I

Skills
  • Computer Skills includes: MS Office Application Suite (MS Word, Excel, PowerPoint, and Outlook)| IVRS Applications | EDC Applications | CTMS Applications
Experience
Senior CRA/Lead CRA, 05/2021 to 01/2023
IconPanorama City, CA,
  • Checked electronic data capturing systems for integrity and compliance.
  • Performed pre-study, initiation, closeout and interim visits to check on study activities.
  • Performed training and sign off visits for junior CRA staff.
  • Provided monitoring support to CRAs allocated to assigned clinical trials with support from CTMs and PM.
  • Oversaw protocol deviation documentation, tracking and escalation.
  • Assisted assigned CRAs in resolving action items.
  • Resolved and escalated to CTM and PM study specific site monitoring issues as identified in the CRA’s Monitoring Visit Reports.
  • Managed study milestones and study metrics.
  • Responsible for study start-up activities including managing essential trial documents.
  • Reviewed and approved monitoring visit reports.
  • Ensured that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File.
  • Provided guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • Negotiated investigator budgets for site contracts with support from CTM and PM.
  • Evaluated proof of eligibility and consent for participants.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Assessed drug storage conditions and procedures to check adherence to standard protocols.
  • Participated in investigators' Meeting.
Senior CRA, 03/2018 to 05/2021
Syneos HealthCity, STATE,
  • Performed site qualification, site initiation, interim monitoring, site management and close-out visits.
  • Conducted Source Document Review of appropriate site source documents and medical records.
  • Verified the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
  • Ensured all assigned trial sites team members are trained and compliant with applicable requirements.
  • Identified potential issues and implements corrective actions independently.
  • Participated in TMF and on-site audits as requested and responded to findings without oversight.
  • Assured compliance with all protocol requirements.
  • Assured effective patient identification and recruitment plan is in place.
  • Assured timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE)
  • Ensured proper storage, dispensation, and accountability of all Investigational Product(s) and trial related materials.
  • Tracked Investigator payments/milestones.
  • Documented and tracked the resolution of all outstanding site-specific protocol-related issues from visit to visit.
  • Attended investigator and assisted with event planning.
  • Assisted with the preparation of study start-up materials and tools, as requested.
Study Start-Up and Regulatory Coordinator , 09/2014 to 02/2018
Manhattan Medical ResearchCity, STATE,
  • Ensured of completion of study start-up documents for IRB submission.
  • responsible for cost analysis of assigned clinica trials and negotiated study budget with sponsor/CRO representative.
  • Managed upkeep of regulatory electronic and hard copy filing systems and archives.
  • Updated in-depth trackers of approvals and submissions.
  • Performed quality review of country and site level essential documents.
  • Screened patient records, databases, and physician referral summaries for identification of prospective
    candidates for research protocols.
  • Educated hospital personnel for participation in protocol conduct, data collection process, and
    related conceptual issues.
  • Organized community outreach programs to boost recruitment for active trials.
  • Submitted fees and applications, tracked status updates and handled all correspondence during regulatory affairs processes.
Education and Training
Bachelor: International Bus & Marketing, Expected in 06/2009 to California State Polytechnic University - Pomona, CA
GPA:
Activities and Honors
Association of Clinical Research Professionals (ACRP) | Member since Mar-2019
Languages
English:
Full Professional
Negotiated:
French:
Native/ Bilingual
Negotiated:

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Your data is safe with us

Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.

Resume Overview

School Attended

  • California State Polytechnic University

Job Titles Held:

  • Senior CRA/Lead CRA
  • Senior CRA
  • Study Start-Up and Regulatory Coordinator

Degrees

  • Bachelor

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in:As seen in: