Maria Teresa Acuero, Mas Email & Phone Number

San Diego, California, Us

• Review, Abstraction, Processing, and Validation of Medical Records (i.e. Delivery, Pediatrics, OB, and Specialist records). Sorts and verifies the accuracy of data entered.• Assess patients for eligibility and determine toxicities related to protocol management.• Evaluates the quality of data submitted and performs data quality checks and data validations. Resolves data discrepancies or errors.• Performs query-based Quality Assurance on study data to ensure thorough documentation and protocol compliance on FDA regulated observational studies.• Review Sponsor Report draft/Annual Interim reports for consistency and review of errors.• Works with the Data Management team to oversee and maintain quality control in coordinator and data manager related responsibilities. Also, works with the team to develop procedures for documentation and archiving results of compliance and quality reviews of MTB operating systems.• Knowledge and understanding of audit requirements involving interpreting and implementing FDA regulations, ICH/GCP guidelines, and compliance issues including oversight of Human Subjects research.• Performs tasks in lieu of the Quality Assurance Manager position. Includes maintenance of Quality System documentation, oversight of study compliance, DOA, study SOPs, and data management documents, and ensuring adherence to these documents according to regulatory and accrediting requirements.• Prepares Advisory Board Charters for MTB Pregnancy Studies. Tasks include modifying and making sure all info and updates are correct as well as obtaining signatures and disclosures from our advisors.• Responsible for ensuring the studies is “audit ready” at all times (project team training records, current regulatory documents, advisory board charters).• Participates in audits and ensures that any observations are addressed appropriately and in a timely manner. Assists the RM in ensuring that project team members are compliant with SOPs and internal guidelines.

Supplied consulting services as SME for reviewing and providing feedback on translated material in the medical and pharmaceutical fields.

Oslo, No

Worked in the research study - The Norwegian mother and child cohort study.* Provided assistance with the preparation of project-related reports, manuscripts, and presentations.* Was responsible in training new staff.* Verified the accuracy and validity of data entered in databases; corrected any errors.* Was responsible for the downloading of "metadata" into the system and data quality control for further data analysis.* Data entry and management into the tracking system.* Analysed and interpreted information on case subjects' or participants' prenatal records concurrently and retrospectively using study protocol.* Responded to study participants' questions about the research.* Tracked the mailing and receipt of the questionnaires using the "Eyes and hands for forms (Read soft)" system.* Medical, Occupational & Industrial coding of the survey questionnaires.* Interacted with persons from other parts of the health system. Served as liaison with local hospitals, OB. Gyn. Department and laboratories.* Managed data from the Norwegian Biobank.* Managed the maintenance of office equipment, ordering and monitoring supplies.

* Extensive knowledge of medical terminology.* Long term experience on computerized transcription of medical journals and x-ray, ultrasound, CT, angio, MRI results; everything that pertains to the Radiology department.* Familiar with and was a frequent user of various hospital-based computer systems; databases, in- and out-patient registration.* Ability to work well under pressure during shifts at the ER & Trauma section of the Radiology department.* Ability to excel in a fast-paced, team environment.* Performed in general, administrative and organizational work.

Support Services for Epidemiology with the NIEHS.* Provided English translations of the Norwegian biological specimen comment files extracted from data from the Biobank.

Worked in the research study - Pregnancy, Heredity and Environment - a case/control study of cleft lip and palate.* Enrolled and followed-up study participants. Contacted them and responded to questions about the research.* Obtained informed consent or research subjects and/or their guardians.* Edited questionnaires for completeness and accuracy; checked for inconsistencies and incomplete information; made edits/corrections under the supervision of the study manager.* Coded self-administered questionnaires using ICD-10 codes, ATC-codes, industry codes and occupational codes.* Created documents and forms utilizing MS software and drafted interoffice memoranda and external correspondence.* Developed and implemented research quality control procedures.*Worked closely with study staff to develop and format study forms and procedures for collecting buccal (cheek) swabs from adults and children.* Assessed eligibility of potential subjects through methods such as reviews of medical records, and discussions with physicians and nurses.* Translated various documents to English and back-translation into Norwegian.* Participated in the data quality control of the database system and self-administered questionnaire in collaboration with the U.S. working team.* Assisted in preparation of periodic progress reports as well as presentation of the research study materials. Assisted also in processing of contractor's invoices and expense reports.* Assisted in monitoring the collection of biological samples such as buccal swabs and blood samples for genetic linkage studies.

Specialized Certificate, Regulatory Affairs For Medical Devices

Continuing Education, Clinical Research

Master Of Advanced Studies, Clinical Research

Professional Certificate, Clinical Trials Design And Management

Continuing Education, Computer And Information Sciences, General

Bachelor'S Degree, Psychology