Anna Fe, Mph, Pmcp Email & Phone Number

San Diego, Ca, Us

Summary: The CTSS will assist the project management team with the planning, execution, and oversight of multi-site clinical trials in our CRO division. The CTSS will also function as the subject matter expert for the electronic Trial Master File (eTMF) system. This position will require an understanding of the basic skills necessary for the application of regulatory requirements, contractual/budgetary guidelines, and CRO level methodologies. Performs duties in accordance with company’s values policies, and procedures. Please note : ProSciento is only considering local candidates at this time. Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion. • Assists Clinical Project Managers (CPMs) with study start-up activities, including but not limited to study-specific form development, regulatory binder/investigator package set and ship up, communications and correspondence, regulatory document submissions, equipment or supply procurement or shipping. • Assists CPMs with internal and external meeting coordination and generates meeting agenda and minutes. • Manages workflow for confidentiality disclosure agreement (CDA) review, submission, and execution, study form reviews by client, regulatory document receipt/review, and eTMF document upload, maintenance, and review. • Acts as subject matter expert (SME) for the eTMF system (knowledge of WingSpan is a plus), including serving as a business administrator, master list updates, validation management, and training for other ProSciento colleagues. • Contributes to the periodic review of the study files for accuracy and completeness. • Assists with upkeep of the clinical trial management system (CTMS) site database and sends feasibility questionnaires to new prospective investigators and/or sites that may participate in a specific project, and with export of applicable study data for eTMF set up. • Assists CPMs with the selection of investigators.

San Diego, California

Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites.· Performs PPD Investigator file reviews and logs findings in CTMS.· Maintains assigned data points within CTMS according to the established conventions within specified times.· Coordinates team conference calls, documents, completes and distributes meeting minutes from internal/client meetings.

Intertek Pharmaceutical Services

•Assisted in the development and maintenance of review schedules and functional area metrics.•Assisted with the maintenance of controlled documents within the Intertek system. Assure compliance to procedures as defined in the Quality Policy and Standard Operating Procedures (SOPs).•Completed on-going review of Project and Administrative Notebooks for accuracy and compliance with Standard Operating Procedures and Bioanalytical Procedures (BPs).•Assisted with developing, revising, and reviewing company SOPs.•Followed Intertek SOPs and update SOPs as changes are made.•Followed GLP guidelines in the laboratory.•Performed general administrative functions, such as making photocopies, filing, scanning, and other related duties as assigned.

Greater San Diego Area

• Logged review activities, maintained review status utilizing Microsoft Access database, and provided status update reports as requested. • Processed Engineering Change Orders as part of the Change Management Process.• Received, classified, scanned, filed, audited, and archived Quality System documents accordingly in centralized record archival system.• Tracked the change process through development, approval, and implementation and compiled data for the creation of metrics and reports for change control activities. • Evaluated problems where analysis of situation's required evaluation of identifiable factors.• Assisted in the documentation of key processes and departmental procedures.• Researched documentation in the electronic change management system, Master Control.

Greater San Diego Area

• Verified insurance benefits to determine cost share amounts for prospective customer responsibility.• Collected all required documentation.• Coordinated shipments of products to customers.• Worked with reimbursement department to ensure data provided meets invoicing requirements. • Worked as part of the support team, including members of the Field Sales team, to ensure proactive communication of prospective customer’s order status.

Greater San Diego Area

• Reviewed complaints and classified issues by complaint criteria• Used and maintained database(s) or logs, provided analyses and trending on complaints.• Supported the filing of regulatory reports with the assistance of the Complaint Management team• Assisted in trending complaint data and notified management of emerging events.• Coordinated with groups who perform additional investigation and reviews investigation reports for adequacy.• Provided basic technical expertise and assisted in handling complaints to comply with current FDA and International reporting regulations.• Supported the review and provided input into closure of complaints and complaint investigations

Greater San Diego Area

• Performed a high volume of data entry of supporting documents accurately for medical testing into a software system• Validated information received on supporting requisition forms.• Processed a high volume of urine and saliva samples in the laboratory by following all laboratory SOP's.• Collaborated with other departments in order to resolve any discrepancies made on the patient requisition forms.• Used Microsoft Outlook for e-mail correspondence within the data entry department and also scheduled meetings with co-workers and higher management.• Complied with all clinical laboratory procedures and HIPAA regulations.

Project Management

Masters, Public Health

Current Student

Bachelors Of Pharmacological Chemistry And A Minor In Psychology, Chemistry, 3.0

Activities and Societies: Slavic UnionI studied pharmacological chemistry and psychology at University of California, San Diego. I also.

Associates Degree, Chemistry