• Manage and conduct ongoing safety surveillance within assigned clinical trials.• Review SAE and SUSAR reports for investigational products in accordance with applicable regulations, guidelines, and SOPs and work practices.• Coordinate review of AEs and SAEs with medical director to ensure coding accuracy, assure timely assessment of events, and identify potential trends and signals in the data.• Evaluate SAEs for regulatory reporting per protocol, investigator brochure and/per package insert, if necessary. • Ensure the timely completion of applicable SAE report regulatory submissions to regulatory authorities. • Perform quality checks of SAE reports and communicate with investigational sites as needed. • Represent Clinical Safety Surveillance in cross-functional team meetings.• Ensure safety management activities are in place and communicated to vendors for each assigned study.• Conduct periodic AE/SAE reconciliation of designated clinical studies.• Create final SAE narratives for clinical study reports.• Disseminate safety related information to internal members and external stakeholders. • Participate in the preparation or review of aggregate safety reports.• Preform quality control within the electronic trial master file (eTMF).• Completion of data entry of case report forms. • Participate in regular review of department SOPs.• Draft and update departmental SOPs and other work practices as assigned and maintain consistency with regulatory guidelines and good pharmacovigilance practices.• Participate in training staff and internal and external audiences.• Routinely liaise with applicable functional areas (Clinical Operations, Regulatory Affairs, Quality and Biostatistics) on drug safety related matters.• Maintain a high level of understanding of federal and international regulations and guidance so as to guide departmental policies and procedures.

AE/SAE reconciliation provided to pharmaceutical, device and biotech companies throughout the lifecycle of a clinical study.Collaboration with study managers, investigational sites and monitors to ensure data between the safety database and clinical database is clean prior to database lock.Provide rolling reconciliation beginning with the start of a clinical trial and continuing through database lock, adhering to strict timelines.Data conventions and query writing.Standard operating procedure, work instruction and data management plan writing.Adverse event case report form and serious adverse event report form and completion guideline development.Serious adverse event narrative writing.CRA recruiting:Vast network of clinical research associates available for remote and onsite clinical auditing and monitoring.

Provide clinical site coordinator support.Completion of data entry, case report forms (CRFs), and query resolution for a Phase I clinical trial.

Assume in-house monitoring responsibilities as needed and required by GCP and contribute to clinical study quality assurance, data management and reporting activities as follows: receive, track and manage serious adverse events (SAEs) for all Phase I-IV pharma and Phase III device clinical trials.Case processing per sponsor SOPs.Develop SAE forms and completion guidelines for pharma and device protocols.Assist in case report form design.Participate in all protocol meetings, giving guidance on collecting and reporting adverse events based on global regulations.Review SAE reports for completeness and clarity and pursue follow-up information as warranted. Generate data clarification queries for investigational sites.Work closely with global investigational sites and study managers on an ongoing basis regarding the collection of SAEs. Generate SAE final study report narratives.Prep annual safety reports, IND annual reports, and clinical investigator's brochures.Created and implemented an adverse event/serious adverse event reconciliation process being utilized in all pharmaceutical and surgical clinical trials. Solely manage AE/SAE reconciliation of safety database (Oracle AERS) to clinical databases for over fifty pharmaceutical and device clinical trials with multiple, global investigational sites. Work closely with the clinical and data management departments as well as CROs.Assist in preparing for FDA and MHRA inspections.Participated in MHRA inspection.Prepare and submit expedited safety reports to local and global regulatory agencies.Prepare periodic trending reports for post-marketing and clinical departments.Generate and contribute to writing SOPs and work instructions.Manage global vision care clinical findings reports.Assist in validation of Oracle AERS test scripts.Excellent knowledge of global reporting requirements for pharmaceutical and device trials.Identify and evaluate issues related to the project and implement resolutions.

Assume in-house monitoring responsibilities as needed for Phase I - II pharmaceutical clinical trials.Develop SAE forms and completion guidelines.Implemented a system for the collection and housing of SAEs.Train staff on adverse event reporting, local and global requirements.Contribute to reporting activities as follows: receive, track and manage serious adverse events (SAEs). Review each report for completeness and clarity and pursue follow-up information.Manage SAE reconciliation for all protocols.Identify and evaluate issues related to the project and implement resolutions. Assist in CRF design.Attend investigator meetings. Trained investigators, coordinators and monitors on reporting SAEs.Assist in protocol development.Provide input on decisions related to processes and procedures.

Develop protocol-specific documents for ease of tracking patients and regulatory documents, to ensure regulatory and protocol compliance.Assist with off-site data collection and creation of status reports for six multi-site projects.Assist with regulatory review of received documents, including the assurance of GCP in informed consent forms.

Conducted all office operations: purchasing, inventory, account management, customer service, public relations, research and development.

Assisted in creating a foundation which will provide monetary funds for small household repairs within the Tampa community.

Provided solution focused/brief therapy to individuals, couples and families.Assisted in agency workshops.