Clinical Research Medical
Resume:
Linda Celeste Ellison
Gainesville, Georgia 30501
Phone: 678-***-****
Email: adbu86@r.postjobfree.com
O B J E C T I V E
To further my experience and knowledge in the field of clinical research. Currently seeking to obtain a challenging position in an environment where I can utilize my education and experience. E D U C ATION
Macon State College & University: Bachelors of Science Macon, GA Completion Date: May 9, 2009
• Healthcare Administration Management Services
• Focus in Case Management & Managed Healthcare
E X P E R I E N C E
Sr. Quality Management & Regulatory Compliance Specialist Sterling IRB: Atlanta Georgia
February 11, 2018 -February 11, 2019
• Provide guidance to IRB members, the administrative staff, research sponsors, and investigative sites on regulatory compliance issues pertaining to the conduct of human research
• Assist in updating the IRB’s registration with regulatory agencies as needed
• Assist with the following to assure continuous quality and compliance of the HRPP: Monitoring of:
• New Policy or revisions to existing policy, to ensure proper implementation by the Board and /or administrative staff, as designated by the IRB Chairman and Institutional Official
• Areas within the IRB, as noted by the Quality Management & Regulatory Compliance department, or as recommended by the management team, where noncompliance with policy has been identified
• Evaluation of:
• Training and Education Program for the Board and Staff
• Board meetings, to ensure compliance with policy and regulations
• Meeting minutes to ensure that IRB meetings are accurately documented
• Internal file audits to ensure compliance with Sterling IRB policies and procedures and applicable regulations.
• Development of training and education sessions for the administrative staff and Board at the request of the Director of Regulatory Compliance
• Develop documentation of training/education sessions attended by Board members and the administrative staff as needed
• Assist prospective/new Board members in the orientation process
• Assist in the generation and processing of regulatory correspondence, including compliance-related Board requested follow-up
Linda Celeste Ellison
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• Assist in ongoing development, implementation, review or revisions to the Standard Operating Procedures (SOPs) and Appendices to comply with local, state, federal and applicable international laws, rules and regulations governing human subject protection
• Assists with the following:
• Scheduling, preparing for, facilitating and responding to sponsor/CRO audits
• Coordinating and facilitating routine size audits
• Preparing for and coordinating for cause audits of research sites as requested by the Board
• Assist in the quality assurance review of controlled documents prior to review and approval by the IRB Chairman and the Institutional Official
• Assist in the preparation and review of the IRB meeting minutes as noted on the Minutes Checklist Sarah Cannon Cancer Institute Regulatory Affairs Specialist Nashville, TN
January 2017- February 11, 2019
• Establishes and maintains a document management system for regulatory paper and electronic files
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with
• local Standard Operating Procedures (SOP’s) for format and content
• Maintains updated physician credentials for network participants and other critical documentation ensuring compliance
• Modifies and/or develops informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA
• Organizes and coordinates IRB documentation for trials
• Provides initial review and triage of IND Safety Reports as delegated by the Principal Investigator, and perform subsequent processing of those Safety Notifications that meet the
• IRB reportable criteria
• Assists any internal or external audit team with any regulatory related issues
• Apprises Regulatory Affairs Manager and Network Management, if applicable, of all study and site-specific regulatory issues for guidance and follow through
• Archives study specific regulatory documentation and correspondence
• Attends network meetings, conference calls and monthly staff meetings as appropriate
• Participates in educational activities and programs
• Maintains strictest confidentiality
• Performs related work as required Mandatory
• Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
• During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
• Knowledge of scientific and clinical research terminology is essential
• Knowledge of IRB, FDA and GCP guidelines required
• Skills: The proficiency to perform a certain task
• Skills in MS Office products including Outlook, Word, and Excel
• Abilities: An underlying, enduring trait useful for performing duties
• Ability to multi task and meet strict deadlines.
• Attention to details in a fast-paced environment Linda Celeste Ellison
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Sarah Cannon Cancer Institute – Regulatory Coordinator Nashville, TN
Jan 2015 – Dec 2016
• Processes regulatory document signature request through electronic signature platform. Tracks documents pending site regulatory signatures.
• Provides site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance.
• Establishes and maintains a document management system for regulatory paper and electronic files.
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.
• Maintains updated physician credentials for network participants and other critical documentation ensuring compliance.
• Triages site requests for regulatory support and identifies correct pathway for issue resolution.
• Attends network meetings, conference calls and monthly staff meetings as appropriate
• Participates in educational activities and programs
• Performs related work as required
• All other duties as assigned
• Assist study activations team with opening new studies for sites (Start-up Documents) Sarah Cannon Cancer Institute - Documentation Control Specialist Nashville, TN
Jan 2014 - Jan 2015
• Manages the electronic filing of IND Safety Reports and assist in processing safety notifications per SCRI policy and related Working Practice Guidelines under the supervision of the Regulatory Affairs Specialist and Lead Regulatory Affairs Specialist.
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content. Organizes and coordinates IRB documentation for trials
• Generate IRB submissions of Investigator Brochures including event summaries for cover letter, compilation of individual submissions, preparation of multiple copies for submission and filing
• Establishes and maintains a document management system for regulatory paper and electronic files; Archives study specific regulatory documentation and correspondence
• Interact with on-site monitors and respond to queries from pharmaceutical company and study monitors regarding Investigator Brochure status and submissions
• Works with Network Management team, study managers and regulatory personnel to achieve goals for quality assurance and compliance
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• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and /or other networks, Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
• Organizes and coordinates IRB documentation for trials
• Assist any internal or external audit team with any regulatory related issues
• Maintains Strategic site credential files and ensure that are accurately up to date Sarah Cannon Bone Marrow Transplant Clinic - Clinical Support Coordinator Nashville, TN
Jan 2011 - Jan 2014
• Schedules transplant patient evaluations including donors as identified by transplant coordinators.
• Scheduling to include: outpatient testing (i.e.: CT/pet scans, EKG, pulmonary function, echo, chest x-rays, skeletal surveys and lab testing) as well as meetings dietician, financial coordinators, social workers, and transplant coordinators.
• Schedules consults following transplant evaluation such as cardiac, pulmonary clearance, psych/social and referrals as needed. Schedules follow-up appointments/ visits for restaging post-transplant from day zero thru two years POST transplant and ensures that all required appointments are completed as scheduled.
• Completes precertification for ALL transplant related testing for patient and donors
• Schedules follow-up appointments/ visits for restaging post-transplant from day zero thru two years POST transplant and ensures that all required appointments are completed as scheduled. Follows up with patients regarding missed appointments. Verifies charts are coded correctly to assure that all restaging tests are performed.
• Creates and maintains a collaborative working environment with program administration, physicians, hospital finance administration and all Tennessee Oncology and Sarah Cannon Blood and Marrow transplant staff to ensure overall program success. Provides D/C packets to referring physicians which include SCBMTP's restaging guidelines, d/c note, immunization guidelines and updated medication list for the transplant patient. Responsible for strict enforcement of HIPPA guidelines. Shepherd Center, Catastrophic Injury Facility - Admin Assistant Atlanta, GA
Aug 1996 - Dec 2010
• Performs administrative and certain clinical duties under the direction of attending physicians and registered nurses.
• Administrative duties include data entry, scheduling medical appointments, maintaining medical records, billing, and coding for insurance purposes.
• Others duties includes data entry of medical procedures and medication orders for inpatient and outpatient procedures.
• Responsible for attending team conferences and in-services and communicating with multi-disciplinary staff members for coordination of care.
• Performs clerical duties to maintain an organized healthcare department and allow medical staff to focus on patient care.
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• Additionally, admit patients, administer and maintain patient records, break down medical charts for record keeping and coordinate billing. Communicate with the clinical staff to ensure all appropriate patient information is gathered. Responsible for strict enforcement of HIPPA guidelines. C O M P U T E R S K I L L S
• Microsoft Office Suite: (Word, Outlook, Excel, PowerPoint, Lync)
• Adobe Acrobat XI Pro
• Lotus Notes
• Signix - Electronic Signature Capture System
• Salesforce
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