Allison Duran Email & Phone Number

Usa

San Diego, California

Home-Based San Diego, Ca

San Diego, Ca

San Diego, Ca (Regional)

Performs all types of monitoring visits for all phases of clinical trials. Responsible for site management and managing study deliverables.

CRA Contractor for Genzyme, Inc.

Sr. CRA Contractor for Johnson and Johnson

Assists Project Management in the development and review of protocol/study design, case report forms, informed consent forms and other study documents.Participates in the identification and recruitment of investigators; develops patient recruitment strategies and materials.Coordinates Clinical Monitors on-site and in-house monitoring responsibilities, schedules and overall project related day-to-day management of the monitoring team.Manages aspects of the clinical projects, including the review and sign-off of monitoring reports (including tracking of reports and assurance of visit frequency per CMP/contract); assists in preparation of monthly status reports.Prepares source documentation and assists in generation of CRF guidelines.Identifies, recruits and manages vendors as required per project scope.Supervises Clinical Assistant(s) assigned to project teams for project related scope.Prepares for and attends project team meetings and provides updates of project performance.Prepares for and attends client meetings; provides follow up with client regarding any study issues as requested by Project Manager.Attends and participates in internal and external training sessions.Monitors the preparation and timely completion of all regulatory filing packages and monitoring trip reports and reviews them for appropriate content.In conjunction with the Project Manager or Project Director, or as delegated, provides study-specific training to study personnel.Indications include: Hypertension in the very elderly (70+ years of age), Parkinson's disease

Perform qualification, initiation, routine and close-out monitoring visits to review case report forms, source documentation, investigational drug accountability and site regulatory files in accordance with ICH GCP guidelines and applicable Standard Operating Procedures. Maintain open and consistent communication with site personnel in order to ensure that monitoring visits occur as directed by protocol timelines, data clarifications are resolved in a timely manner and act as a liaison between site personnel and the sponsor to ensure that site questions and concerns are resolved in a timely manner.Review data listings at interim timelines and study closeout to ensure data in the study database is complete and accurate.Train junior Clinical Research Associates and newly added study monitors by review of study protocols and co-monitoring.Indications include: Multiple Sclerosis, Alzheimer's disease and Post-Op Pain

Perform qualification, initiation, routine and close-out monitoring visits to review case report forms, source documentation, investigational drug accountability and site regulatory files in accordance with ICH GCP guidelines and applicable Standard Operating Procedures. Maintain open and consistent communication with site personnel in order to ensure that monitoring visits occur as directed by protocol timelines, data clarifications are resolved in a timely manner and act as a liaison between site personnel and the sponsor to ensure that site questions and concerns are resolved in a timely manner.Train junior Clinical Research Associates by review of study protocols, co-monitoring and writing evaluation reports.Develop tools to assist with collection of data, monitoring protocol compliance and recording drug accountability. Indications include: COPD, Hepatitis C and prevention of local catheter site infection.

Performed qualification visits in accordance with ICH GCP guidelines and applicable Standard Operating Procedures.Reviewed project-related materials and literature to develop understanding of the protocol and therapeutic area.Maintained open and consistent communication with site personnel in order to ensure that monitoring visits occurred as directed by protocol timelines and site questions and concerns were resolved in a timely manner.Performed feasibility studies in order to recruit Investigators for new protocols.Indications include

Performed qualification, initiation, routine monitoring and close-out visits to review case report forms, source documentation and site regulatory files. Ensured that clinical data and regulatory documents were accurate and in compliance with the study protocol, GCP, FDA regulations and ICH guidelines.Tracked investigational drug accountability and clinical supplies at investigational sites in accordance with applicable Standard Operating Procedures and FDA regulations.Maintained routine communication with Investigators and site staff and acted as a liaison between the site and the study sponsor.Provided assistance with various aspects of planning, conduct, tracking and completion of clinical studies.In-house duties included site recruitment, IRB submission review, protocol development, informed consent development, case report form development, source document development, regulatory document collection, serious adverse event documentation and follow-up and assisting with administrative aspects of study completion.Indications include

Assisted Clinical Research Associates with the administrative tasks related to running clinical trials. Duties included clerical work, handling of study documents and files, writing of data queries, protocol and case report form development, data management and shipment of study supplies to study sites.Received monitor training from experienced Clinical Research Associates. Training included on-site monitoring visits for initiation, routine and close-out visits, in-house training on new protocols, drug accountability, writing monitoring visit reports and writing follow-up letters.Established and implemented a system for a central regulatory master file.

As part of CRA training, was assigned lead study coordinator responsibilities for "A Randomized, Parallel, Open-Label Adrenal Suppression Study Comparing a Topical Corticosteroid of Varying Strength in Subjects with Plaque-Type Psoriasis". Responsibilities included subject recruitment, conducting study visits with subjects, source document and case report form completion and acting as the primary liaison between the study sponsor and Principal Investigator.

Molecular Biology

Graduate Program; A Ph.D. Program, Biomedical Sciences; Biomedical Sciences; Biochemistry, Molecular Biology And Cell Biology

a focus in the field of Virology. Core courses included education; Completed research rotations in three laboratories Presented my.

Bs, Molecular Biology

Bachelor Of Science Degree Obtained, The Field Of Molecular Biology

Upper division coursework included molecular biology, cell biology, structural and metabolic biochemistry, genetics, microbial genetics.