Seasoned professional with over sixteen years experience in clinical research including data management (entering/reviewing), in-house monitoring and evaluation of data, legal and HR. Additional experience as a legal assistant/paralegal specializing in real estate closings.
Monitored multiple databases reviewing discrepancy (edit check) output and validation listings based on data entered into the CRF database. Based on this review, queried or applied self-evident corrections or other global rulings permitted, per the Clinical Data Validation Plan for the assigned projects. Resolved queries correctly answered and re-queried where appropriate. Provided assistance and guidance to other Clinical Data Associates with the above tasks. Reviewed queries, self-evident corrections, and the application of global rulings, proposed by staff responsible for the coding of CRF terms for adverse events, medical history, and medications against medical coding dictionaries.
Served as the primary contact and company representative managing sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines. Managed training on the study protocol, informed consent process, data collection requirements/data collection tools, reporting requirements, and patient reported outcomes instruments in compliance with applicable regulations and guidelines. Assured timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans. Reviewed eCRFs completed by sites and assisted the site in resolving queries and/or other identified data collection issues.
As primary contact and company representative for study sites, developed and maintained study documents such as CRFs and CRF completion guidelines, mailing/faxing materials, newsletters, telephone scripts as well as document collection and monitoring plans. Served as a central contact point for public inquiries regarding studies. Prepared status reports for assigned projects to sponsor, Project Leader, and Management. Assisted in the development of patient enrollment strategies. Prepared and distributed study-specific materials to potential patients and potential referring physicians.
As primary contact and company representative to study site, health care providers, patients, investigators and coordinators, developed and maintained study documents such as CRFs and CRF completion guidelines. Created and/or maintained Informed Consent and/or Clinical Trial Agreement. Provided support for study awareness and patient recruitment, including manning toll-free public call center. Prepared, distributed and/or interpreted regular status reports for assigned projects. Assisted in the development of patient enrollment strategies. Conducted patient pre-qualification procedures. Prepared and distributed study-specific materials to potential patients and potential referring physicians.
As primary company representative assisted in the development and maintenance of study documents such as CRFs and CRF completion guidelines, mailing/faxing materials, newsletters and telephone scripts. Served as a central contact point for public inquiries regarding studies. Performed in-house site support activities, researched and responded to various site inquiries (study materials, protocol, systems use, study documents, CRF conventions, queries, payments, etc.), and appropriately tracked and documented these interactions.
Produced and/or assembled all documentation necessary to initiate a patient registry study, assisted in drafting SOPs, study management plans, and various departmental instructional documents, coordinated the packaging, shipping, and tracking of supplies and materials to study sites with appropriate Sponsor, consultants, advisory committee members, and CRL personnel. Performed data entry for patient registrations, and assisted with case file auditing. Prepared and tracked patient and Health Care Provider reimbursement payments, enrollment and follow-up packets to health care professionals and patients.
Drafting and preparation of legal documents, maintenance of project-tracking files, confidential legal files, personnel and benefits files, reports, and calendars, recruiting files. Scheduled interviews, checked personal references, and prepared written correspondence to interview candidates. Prepared various personnel reports and maintained job descriptions notebook, assembled and maintained employee orientation/benefits packages and employee guide books.
Transcription of all legal documents, correspondence, and memorandums (dictaphone and shorthand) and scheduling of appointments for two attorneys. Complete preparation of real estate closing documents from opening of file through routing closed package to lenders and/or clients.
Preparation of legal documents, and correspondence, scheduled meetings, took minutes, prepared documents for real estate transactions, assisted in closing transactions, logged data for billing.
Processed insurance applications, renewals, endorsements, audits and cancellations for residential and commercial lines.
Clinical Research with data management, call center, HR, legal, and QA. Real estate closing documents. Customer service commercial and residential insurance.
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