Megan White Email & Phone Number

Albertville, Mn, Us

• Assists in clinical study protocol, annual report, and final report writing.• Reviews case report form data for accuracy and completeness.• Creates and resolves data queries.• Assists with data audit activities.• Takes part in process improvement activities related to study document retention and reports.• Assists with maintaining study documentation to ensure data audit readiness.• Ensures regulatory and protocol compliance.• Develops study start-up materials including informed consent forms, activationletters, and invitation letters.• Performs telephone close out visits with clinical sites.• Drafts serious adverse event narratives.• Reviews adverse event forms, reviews/redacts source documentation, and requestsadditional data as needed.• Prepares adverse events for Data Safety Monitoring Board activities.• Reviews imaging source (e.g. echocardiograms) from sites for submission to Core Laboratories.• Assists with training of new employees.• Performs training of site personnel including Principle Investigators, ResearchCoordinators, and Regulatory personnel.• Experience with IDE, PMA, and Investigator Initiated studies.

•Creates and manages study files and regulatory binders.•Tracks and distributes clinical study documents including: documentation, agreements, site approvals, IRB’s, EC’s, data compensation, etc. •Interacts with site staff for data collection and follow-up.•Completes data entry.•Reviews study documents including completed case report forms, query resolution forms, draft CRFs and edit checks to ensure practicality of data entry. •Proposes solutions, proof reads, and makes formatting suggestions to case report forms.•Assists with periodic internal file reviews of clinical study files for completeness.•Assists study team with critical study document finalization, such as contract amendments, informed consent revisions, etc. •Actively participates in the design and user acceptance testing and timely feedback of study management reports based on protocol requirements.•Creates accurate and consistent reports for assigned centers as requested, following established practices for the study.•Assists with clinical report development (interim, final, regulatory, committee, etc.). •Assists with monitoring tasks, such as regulatory file reviews and preparation. •Assists with meeting planning and preparation for investigator and committee meetings. •Actively participates in core lab responsibilities.•Prepares and distributes team meeting minutes following each meeting.•Assists with training of new clinical team members.•Contributes to ongoing departmental process improvement efforts.•Assists Clinical Research Associates (CRAs) with site management responsibilities.

•Processed work completely and accurately (e.g. documents, invoices, orders, payments, requisitions, mail, claims, logs, inventory, specimens/samples, etc.) within departmental guidelines.•Audited/verified the completeness and accuracy of information and reported the discrepancies between desired performance and actual performance to appropriate personnel. •Performed administrative support duties (e.g. maintained records, generated and/or sent reports and communications, maintained databases, entered data, answered phones, filed, etc.) completely, accurately and within established time frames. •Provided complete and accurate resolution to all user inquiries or redirected the inquirer to appropriate resource(s) in a timely manner.•Notified management of trends, client/customer issues and concerns, and reported all problems in a timely manner.•Adhered to company compliance policies in decision making.•Performed DOT-regulated forensic urine drug screen collections. Assisted customers in understanding the steps involved, answered any questions from the public relating to the process and completed the collections according to the requirements. Ensured that the collections are processed completely, accurately and within the guidelines. •Created medical requisitions from physician orders for patients needing lab work. •Performed all of the compliance and safety training of new specimen accessioners. Assisted in the accessioning department when short-staffed.•Ordered, maintained, organized, unpacked and distributed laboratory materials.•Archived medical requisitions and all other company documents.

•Performed a variety of routine clerical duties (e.g photocopying, faxing, filing, etc.) completely, accurately and within established time frames. Restocked supplies and notified appropriate personnel of potential and/or actual stock shortages.•Disinfected assigned equipment and/or areas according to department protocol and completed documentation of disinfection schedules for all assignments scheduled.•Accurately recorded all specimens received and verified that all specimens were properly identified in accordance with department guidelines.•Preparation of specimens for clinical testing.•Assisted the supervisor with performing various assigned responsibilities (e.g. compliance, troubleshooting, making workflow recommendations, etc.)

•Evaluation of animal behavior to determine adoptability and safety to the public.•Developed veterinary technician skills through animal examinations.•Became familiar with business computer documentation applications by entering reliable and accurate medical reports.•Acquired the ability to pay attention to detail and check for complete accuracy.•Gained excellent communication skills and the ability to effectively establish relationships with customers by assisting with animal adoption and customer service.

Bachelor Of Science (B.S.), Biology, General

Associate Of Arts (A.A.), General Studies