Salina Simon
Grovetown,GA
Summary
Self-motivated Regulatory Affairs Associate holding 6 years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Associate
Translational Drug Development
06.2023 - Current
- Drafts project plans and creates project documents for review prior to Sponsor review, as assigned
- Acts as a central contact and provides expert guidance to the clinical team for designated project communications, meeting coordination, meeting minutes, correspondence, and associated documentation
- Coordinates activities on clinical trials, including active participation on weekly Sponsor and Investigator calls, maintaining project trackers, and communicating on behalf of the PM to the Sponsor, investigative sites, and vendors as appropriate
- Schedules and maintains organization of all clinical project meetings
- Accurately updates and maintains clinical systems within the appropriate project timeline
- Collects and submits documents for assigned Trial Master Files (TMF) per standard guidelines, to ensure continual TMF maintenance in an audit-ready state
- Routinely perform TMF document Quality Checks (QCs)
- Prepares, handles, distributes, files, and archives clinical documentation and reports in a timely manner
- Prepares and distributes agendas and minutes from Sponsor and Investigator for team meetings with review from the project management team for accuracy within established deadlines
- Maintains accurate team contact lists for every assigned project, proactively gathering information, and updating the contact list
- Ensure that the contact list is uploaded to the TMF, as required to meet Standard Operating Procedure timelines
- Gathers, tracks, and maintains project and site essential regulatory documents
- Provides cross-functional project support to entire Clinical Project team
- Prepares and compiles trial related materials for investigative sites, including Investigator Site Files (ISF) materials, site electronic binders, site instruction manuals, and trial templates, forms, and plans
- Acts as Clinical Trial Associate back-up during absences as needed based on individual trial needs
- Mentors and assists with training of Clinical Trial Associates
- Assists with the development and implementation of clinical policies and procedures
- Performs other related duties as assigned.
In-House Clinical Research Associate II
Premier Research
01.2021 - 06.2023
- Managed and supported site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites
- Served as the secondary contact for sites supporting CRAs/CL to convey project information and for study-related questions, discussed site-specific recruitment, followed-up on outstanding items, and ensured sites are receiving support necessary to meet study expectations
- Built strong, collaborative relationships with investigators and staff at assigned clinical sites
- Reviewed site performance metrics and worked with assigned sites to ensure recruitment goals were met, data entry and query resolution was timely and of high quality, study files were inspection-ready, and monitoring issues were closed in a timely manner
- Identified and escalated site performance and quality issues to the Clinical Lead (CL) in a timely manner
- Partnered with Clinical Research Associates (CRAs) to ensure seamless management of assigned clinical sites
- Frequently communicated with CRAs to share updates on assigned sites, discussed site issues and concerns, and defined actions for resolving issues and deficiencies at the site; including dissemination of information according to the study-specific communication plan between sites, in house and regionally based staff to ensure project success
- Assisted CRA with the preparation and follow-up activities for on-site monitoring visits by participating in pre-visit calls with CRAs and taking responsibility for the resolution of issues identified during on-site visits that can be handled remotely
- Partnered with CRA to ensure the proper reporting and follow up of SAEs
- Provided study-specific training to site staff following study initiation
- Managed or assisted with study feasibility activities including but not limited to, assisting with development of feasibility survey, potential site list, collection of feasibility data, and reporting of results
- Performed ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines
- Ensured all regulatory documents and study supplies were maintained during the lifecycle of any assigned project in collaboration with the assigned CRA and SSUA
- Provided site and CL support to ensure clinical deliverables and site activation milestones were met
- Demonstrated understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and adherence across assigned sites
- Demonstrated understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and SOPs
- Collaborated with the CLs and PMs to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics
- Monitored recruitment remotely through IVRS and EDC systems and/or communication with sites
- Contributed to the study related tracking systems and tools to ensure project status reports remained current
- Assisted the project team in preparation for audits/inspections and was responsible for the quality and completeness of clinical trial documentation
- Collaborated with CRA and/or CL to ensure that Corrective Action Plans (CAP) with investigative sites were overseen
- Contributed to/assisted with the Risk Based Monitoring team to follow-up on specific site related signals/actions issued during risk meetings per the study plan
- Mentored junior In House CRAs (IHCRAs)
- Assisted in the development of study documents
- Identified project risks or obstacles and collaborated with CL/PM to identify solutions
- Conducted remote source document review with appropriate training and sign off
- Conducted remote site qualification visits and or closed out visits, with appropriate training and sign off
- Participated in departmental initiatives
- Performed other duties as assigned
- Attended meetings as required (internal/external)
- Contributed to Premier process improvements and development
- Worked with knowledge of quality/scope/timeline and budget parameters
- Completed timely entry of hours worked and project codes per time entry guidelines
- Coordinated the ordering, tracking, accountability of clinical supplies as requested
- Trained new CRA's regarding the eTMF system.
Clinical Trial Associate / Regulatory Affairs Associate
LivaNova USA
04.2018 - 03.2021
- Maintained regulatory files to ensure the company's compliance with regulatory requirements
- Participated in meetings with regulatory officials for purposes related to market approval
- Was responsible for preparing regulatory submissions (510(k); IDE; IDE Supplements; PMA; PMA Supplements, CE Marking, etc.) for submission to the FDA and International Regulatory Agencies
- Regulatory Dossier submitted by CTD (common technical document) as needed
- Completed DEKRA EU MDR submissions for all device models
- Requested Certificate of Foreign Government from the FDA
- Was responsible for apostille, notarizing, and legalizing company documents, DEKRA ISO Certificates, and CFG's
- Completed FDA Establishment Registration yearly to register medical devices
- Paid invoices for US Legalization, Apostille, Export Certificates
- Coordinated the tracking, logging, and receiving of clinical trial documentation and supplies
- Assisted in the coordination of internal review and signature of clinical trial agreements, contracts, and non-disclosure forms
- Maintained internal record keeping system(s) in conjunction with clinical research associate (CRA) internal/external staff, and sites, including maintaining and auditing data, providing status and activity reports as required
- Set-up of (electronic) Trial Master Files ((e)TMF) and in-house filed TMF documents in the appropriate files according to the SOP and Good Clinical Practices guidelines (i.e., ISO 14155)
- Supported the study start-up and site selection process (e.g., preparation and follow-up of Confidentiality Agreements, retrieve completed site selection questionnaires, maintains site selection tracker)
- Coordinated translations of study documents
- Under general supervision, was accountable for the timely filing and tracking of study essential documents and for ensuring completeness of the Trial Master File, Sponsor Site File, Investigator Site File, and Country Study File to ensure readiness for audits and inspections
- Supported the study team in general study conduct activities: meeting organization, newsletter, and presentation preparation, mailing to sites and general correspondence
- Coordinated the ordering, tracking, accountability of clinical supplies as requested.
HR Assistant / Office Support Specialist
GEO Group Inc.
11.2015 - 04.2018
- Welcomed new employees to the organization by conducting orientation
- Maintained facility personnel files for all current employees
- Assisted all staff and supervisors in understanding policies and procedures described in the Company's Employee Handbook
- Assisted in the hiring process by placing newspaper ads, posting openings with department of labor and other agencies; ensured completeness of application, logging all applications
- Conducted reference and background checks as required by contracts before a job offer is made
- Travelled as needed to conduct an annual corporate audit of 18 staff
- Processed all business office responsibilities including accounting receivables, accounts payable, payroll, inventory control and general office management
- Assisted the Facility Director in any needed area.
Office Manager
Antilles Resorts Management
12.2013 - 08.2015
- Performed bookkeeping activities, such as balancing accounts and conducting nightly audits
- Performed accounts payable and account receivable, and payroll activities
- Plan scheduled or supervised the work of other employees
- Maintained operations by following policies and procedures
- Trained new employees
- Travelled as needed to Europe with manager to promote resort
- Performed international travel coordination to Europe yearly.
Education
Bachelor of Arts in Business Administration -
Oakwood University
01.2013
Skills
- Electronic Data Capture
- Investigational product management
- Informed Consent Process
- Regulatory Submissions
- Clinical trial management
- Source Document Verification
- Interpersonal Skills
- Self Motivation
- Protocol amendments
- Ethics Committee Submissions
- Records Management
- Attention to Detail
Certification
- Collaborative Institutional Training Initiative (CITI) Certifications: Good Clinical Practices (GCP)
- Human Subjects Research
- Responsible Conduct of Research
Therapeutic Areas
Cardiology, US and Global - 3 years - Post and Post Market Phases
Neurology, US and Global - 3 years - Phase III
Oncology, US - Prostate - 2 years - Phase II
Oncology, US - 1 year - Phase I/II/Ib
Psychiatry, US and Global - 3 years - Phase II
Timeline
Senior Clinical Trial Associate
Translational Drug Development
06.2023 - Current
In-House Clinical Research Associate II
Premier Research
01.2021 - 06.2023
Clinical Trial Associate / Regulatory Affairs Associate
LivaNova USA
04.2018 - 03.2021
HR Assistant / Office Support Specialist
GEO Group Inc.
11.2015 - 04.2018
Office Manager
Antilles Resorts Management
12.2013 - 08.2015
Bachelor of Arts in Business Administration -
Oakwood University
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