tmf document specialist i intern resume example with 7+ years of experience
JessicaClaire
, , 100 Montgomery St. 10th Floor(555) 432-1000, resumesample@example.com
Summary
Organized and motivated clinical research professional ready to work. Highly motivated, reliable professional eager to apply my exceptional organizational skills and patient support background to a clinical research role. Experienced in regulatory document management for pharmaceutical and medical device trials. Seeking a Clinical Research position and opportunities to expand skills while facilitating company growth.
Education and Training
Expected in 12/2022 to to Associate of Applied Science | Clinical Trial ResearchDurham Technical Community College, Durham, NCGPA:
Expected in 06/2010 to to High School Diploma | Southern School Of Energy And Sustainability, Durham, NCGPA:
Skills
Electronic data capture (EDC), Metadata, eTMF, CTMS, TMF
Microsoft Office ( Word, Excel, and Power Point and MS Project)
Regulatory Compliance
Administrative coordination
Experience
01/2022 to 12/2022TMF Document Specialist I InternGn Group | Cupertino, CA,
Conducting training and meetings with project teams
Responsible for ensuring study documentation is in a final state for migration purposes and conducting query resolution with appropriate personnel
Strong knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
Oversight of documents (e.g. FDA 1572, CVs, FDF, etc.)
Providing back up management support to the Manager, Document Control and Senior, eTMF Analysts
Providing other support to Manager, Document Control, and Senior Management, as assigned, and performing other duties, as required
Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
Process study documentation in accordance with standard operating procedures, work instructions GCP, ICH Guidelines and study specific
Document collection activities, support the set up maintenance and closure of TMF repositories
Ensures the security and compliance of all documents related to active and archived projects
Ensure that each document is finalized only when it meets all the quality and compliance criteria per project specific guidelines
Attended meetings and trainings to advance professional knowledge
07/2021 to 11/2021Regulatory Affairs Specialist InternLindsey Regulatory Affairs Consulting | City, STATE,
Responsible for data maintenance regarding submissions in the regulatory tracking database for all regions
Research regulations and guidelines and interact with domestic and international regulatory affiliates/distributors to provide effective regulatory assessment of proposed changes to medical devices
Prepare official submissions to regulatory agencies for new or modified products.
Advise and collaborate on regulatory requirements to support new product development, product modifications, product registration and regulatory submissions.
Manage updates to internal regulatory databases
Ensures compliance with regulatory agency rules and guidelines for paper and electronic submissions. Provides update to internal documentation, as appropriate.
Organized and maintained all files related to regulatory actions
Helped with projects surrounding the MDR technical file remediation
Utilizing different documentation platforms and software
Gained medical device knowledge from different clients
Answered compliance for various submissions
Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services
Responsible for data maintenance regarding submissions in the regulatory tracking database for all regions
10/2018 to 06/2021PAP CounselorMcKesson Specialty Health | City, STATE,
Communicated with prescribers to verify medication dosage, refill authorizations and patients' information
Communicated with patients to collect information about prescriptions and insurance provider information
Verified patient data and billing information to discover and resolve erroneous bills due to system errors
Answered incoming calls and addressed questions from customers and healthcare providers
Collected personal data and insurance information from patients to complete intake paperwork
Consulted with staff, insurance provider and family about treatment recommendations and progress
Documented meetings, interventions and contacts with clients to optimize care
06/2015 to 09/2018Patient Care CoordinatorDuke Health | City, STATE,
Followed document protocols to safeguard confidentiality of records
Data entry, Document management, and updated customer accounts, addresses and contact information within management databases
Liaised effectively with patients, doctors and staff members, assessing medical charts and promoting high level of communication and interaction
Provided patient education to explain services and procedures
Facilitated communication between patients and staff.
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