Doris Murray Email & Phone Number

Dublin, Ie

Support and collaborate our Monitoring Team, (GCPM), GCTM, RCTM and CTA. Advance clinical research working with outsourced services, pharmaceuticals, biotechnology, medical device, vendors, and public health organizations. Adhere to internal SOPs, GCP, FDA, ICH, policies and local regulatory requirements. Support the study team in performing site feasibility and/or country feasibility. Provide Support to various projects• Organizes Study Team members in SPO eClinical, Investigator meetings, Maintain Tracking and milestone. The TMF Dash board monthly review of Studies which includes TMF Timeliness and Quality Metrics, QC quarterly reports, In progress (D&A, Annual Planner and FAQ Logs), Overdue milestone >30, 60, 90 day, Documents uploaded in eTMF, Collate relevant study information, Strong Administrative skills, CTS Transition From, CAP report weekly, update Spotfire as needed, Vendors: Signant Health, LabCorp_ Labs, Almac_IRT, Clariness_Recrutiment, Reify, MESM _Equipment, support several team members, excellent written, verbal and communication skills, work with multiple studies in various countries to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Host regulatory inspection, update team and project team, regulation, train staff, update KSIF, eClinical, SPO, fulfill client needs as require, attend meetings as required, provides training, as necessary

Dublin, Ie

Durham, North Carolina, Us

Coordinated clinical research studies as lead under the direction and delegation of the PI and primary contact for CRAs. • Maintain essential study start-up documents, perform site monitoring visits in-house, preformed regulatory requirements, i.e., Good Clinical Practice (GCP), proper conduct of the protocol and adherence to applicable regulations, tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF), review Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual for collecting, preparing labs for shipment or in house analysis, recording AE and or SAE, reporting protocol deviation, training of staff, document training, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). • Organizes and schedules all necessary tests and procedures with participants, assures the highest standard of care, protects subjects' well-being, obtains informed consent, acts as a volunteer advocate.• Ensures accuracy and completeness of study documentation by providing timely updates to protocols, ICFs, Case CRFs, and EDC systems, performing data quality checks, and prompt query resolution. • Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists staff in completion of SAE reports. • Assists with project planning, logistics, and coordinates study procedures, collects and labels specimen tubes and containers, inventories supplies, and sets up or troubleshoots study equipment.• Performs a variety of complex clinical research procedures including but not limited to phlebotomy, sample collection and processing (aliquoting & centrifuging), vital signs, ECG recording, cannulation, cardiac telemetry monitoring

Durham, North Carolina, Us

Durham, North Carolina, Us

•Sponsors, sites, and trial personnel. Receive and triage incoming safety phone calls. Provided routine Coordinate DCI membership leadership review, tracking review process, notifying applicant of decision, updating institutional databases. Manage process for review of member publications, including communicating instructions to all DCI. Members, tracking completion of reviews, troubleshoot any issues and assist members as needed.•Manage and maintain Membership database. Manage communications and serve as primary liaison to DCI Members. Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s [DCI] Safety Team•Day-to-day operations related to the collection, review, interpretation, and documentation of adverse events in the department’s databases. Sponsored clinical trials conducted within DCI to ensure adherence to protocols and applicable clinical research regulations, both internal and external collecting Samples, storage of new product, maintain inventory. Prepare and distribute announcement/Request for Applications (RFA); develop application/review process Timeline. Tracked submitted proposals; coordinate review of applications; notify applicants of review outcomes.•Collect progress reports; track awards and outcomes; manage and maintain award database.Coordinate External Scientific Advisory Committee meetings, including preparation of presentation templates and program metrics for all presenters.•Coordinate programmatic sections of CCSG renewals, including preparation of templates, program metrics and ensure timely submissions.•Prepare program metrics reports for leadership and grant renewals.•Collaborate and communicate with DCI staff, faculty, and senior leaders as required. Be proactive, present ideas for improvements and efficiencies.

Raleigh, Nc, Us

Clinical Research Coordinator Fast Track; In-depth Clinical Research Training – (Total Course work, 230hours) Internship• Trained to execute clinical trials protocols while adhering to FDA/CDER regulations, safety and investigate the response to treatment. Maintained data using good documentation practices (GDP) while ensuring and following, attributable, legible, contemporaneous, original and accurate principles (ALCOA-C). Maintained e-Reg Binder-Red Cap, EDC, Source Doc., performed quality assurance, monitoring and query resolution. Conducted Drug Accountability, Identifying and reporting of adverse events (AEs) and serious adverse events (SAEs). Maintained essential documents (1572, DOA, Training Logs, ISF, etc.),• Trained Logs and other ISF documents. Identification and validation of Investigator New Drugs.• Updated database, participant reimbursement. Conducted clinical trials

Dallas, Texas, Us

Provided excellent customer service to all customers (both internal and external).Provided support to all residential inbound calls from customer agents and third party vendors. Provided resolution of customer’s issues and concerns. Recommended and corrected customer issues with root cause analysis. Experienced with broadband, FIOS Data and Video and VoIP. Knowledgeable of the following application/systems: CRM and Non-CRM DPI, DSL Order Tool, Dynamics, Electronic Bill Payment Processing (EBPP), Workflow Manager, ESP, INET Portal

Durham, North Carolina, Us

• Collaborated with scientists, investigators, lab members. Prepared presentations for sharing knowledge gained. Screened human serum treated with HIV Vaccines. Presented experimental data with Laboratory Manage. Documentation of laboratory and computer logs detailing experiments and analysis performed. Prepared for in-house audit while maintaining GCP and GCLP. Performed various research laboratory techniques. Collect and evaluate data. Calibrate instruments. Tested HIV cohort studies received from Africa. Preformed Luminex or Bio-Plex Assays and Protein Assays. Maintain vendor contact for supplies.

Maintain the growth of cell in artificial medium; maintain tissue culture for animal cells and human cells. Maintained tissue culture vivo assays. Maintained lab and safety procedures required for Bio-Safety Laboratory-2(BSL-2) facility microscopy, computer software (Word, Excel, and Soft Max Pro., Etc.). Perform all aspects of a study such as scheduling, collecting, monitoring data, and presenting data. Trained collaborating members. Conduct In vivo, In vitro experiments, drug administration and surgery to obtain tissues for experiments, processing of tissue, various arterial and organ.•Gene therapy vectors; experience with isotopes and monoclonal antibodies for radiotherapy and radio immunotherapy, tissue homogenization, and PK/PD support. Coordinate with study monitor on study issues and effectively respond to monitor-initiated questions.

Associate Of Arts And Sciences - Aas, Medical Science

Certification, Medical/Clinical Assistant