Robin D. Email and Phone Number

Site management, regulatory, SDR, SDV, queries, remote monitoring visits, remote co-monitoring, adhoc reports, assisted CTL w CRA monitoring visit assignments; laboratory, vendors and therapeutic area -Oncology Phases I-IV.

Help desk Support; Timekeeping; Hyperfinds Kronos Workforce Solutions & HRIS Systems

Site Management

Site Management

Track study related activities for Phase II-IV clinical trials.  Generate reports in various applications to assist the Clinical Scientist to perform clinical data review Provide administrative support to clinical projects under direction of line manager, Clinical Team Leads and/or other designated clinical team members. May assist with general administrative functions as required.Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. May perform assigned administrative tasks to support team members with clinical trial execution. Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesKnowledge of applicable protocol requirements as provided in company trainingComputer skills including proficiency in use of Microsoft Word, Excel and PowerPointStrong written and verbal communication skills including good command of English languageEffective time management and organizational skills Attention to detail and accuracy in workAbility to establish and maintain effective working relationships with coworkers, managers and clients

Reviewed Informed Consent Form (ICF) to assure compliance with Good Clinical Practices (GCP) and ICH guidelines;1st reviewsPerformed site specific naming conventions for essential Assisted with study site packaging of IB documents and shipment labelingAttended sponsor conference meetings for sitesPerformed debarment checks for PIs and SubIs named on 1572Submitted documents for TMF submissions as requestedPerformed other duties as required

Job Titles:Customer Service, Escrow Anaylsis,Quality Reviewer; REO Vendor Managerr Support,Title Curative Specialist, Supplement MI Claims Support Specialist, Foreclosure Timeline Management, Financial Services Representative

Assisted with design of electronic version of study questionnares in Red Cap databaseAudited hard copy study questionnares for completeness and correctnessAssembled, Packaged and Mailed study materials to study participantsUpdated consultants database with returned subjects' study informatiionAssisted with other clinical research adminstrative tasks as needed

Maintained documentation for clinical trials studies.Assembled and inspected patient kits.Responsible for all printed material used for packaged patient kits.Assisted manager with scheduling print jobs and maintaining the assembly schedule.

File order documents as appropriate for laboratory supplies received and shipped.Initiate ongoing communication with laboratory personnel and/or vendors in regards to laboratory supply orders via telephone, faxes, or email. Research and resolve problems for internal and external customers. Manage customers' accounts and promote sales and product assistance.

Maintained documentation for production of pharmaceutical products according SOP's and cGMP.Responsible for inspection of all products as progress through assembly line.Assisted as a team member of rotating assembly line by operating mechanical machinery at each station.Assisted in the sterilization of machinery and clean up in product change over according to the SOP's.

Maintained documentation and operated machinery in the production of pharmaceutical drugs.Responsible for inspection of all drugs from hopper, packaging and shipping.Initiated clean-up and sterilization of drug product batch changeover. Maintained current GMP’s, SOP’s and other guidelines.

Answered customer needs regarding problems with test information, specimen requirements, and prepared necessary affidavits for client's approval.Provided/Performed all administrative work according to laboratory procedures and regulations required to process and follow up with client before submitting specimens for testing.Checked for accuracy and document any discrepancies.Maintained familiar and current with lab procedures and certification.

Unpacked high volumes of donor urine samples to initiate forensic drug testing.Unpacked specimens from branches or ports and routes specimens by type to various staging areas.Prepared and aliquoted all specimens received for testing in designated laboratory departments or locations such as staging of specimens, centrifuge, separate serum, and blood smears.Prepared excess specimen samples for storage; resolved and documented problem specimens.Maintained current GLPs, SOP's, certifications, and other regulations.