Candace Knight Email & Phone Number

Chapel Hill, Nc, Us

Durham, North Carolina, United States

• • Constructs study designs for sample metadata in Watson LIMS based client’s clinical protocol • Structures and clean sample metadata for import into electronic sample management systems (eSMS)• Coordinates timelines between sample management staff and the analytical teams for sample processing in preparation for analysis• Troubleshoots LIMS related issues related to sample importation, sample metadata and study transfers• Facilitates discrepancy resolution for sample metadata with the client/sponsor, updating all necessary information. • Supports software validation and processes in ATLAS and LIMS version 7.7 • Leads sponsor audits, outlining Sample Management processes and procedures.

Durham, North Carolina, United States

• Shadow members of ongoing clinical studies in various research activities including study participants’ drug infusion visits, in clinic follow-up visits, and documentation of each encounter.• Collaborates with the team’s IT Analyst in developing data collection in REDCap EDC and data management procedures for ongoing studies.• Contributes to organizing study data and standardization of fields through Excel templates for migration into REDCap EDC.• Assists in quality checks of source documentation to ensure they meet ALCOA+ guidelines for data integrity.

Durham, North Carolina, United States

● Served as a liaison for Sample Management between the Process Development and Analytical Development teams.● Processed sample submissions using LabVantage and MS Access● Managed sample inventory and tracking utilizing MS Access and Excel.● Fulfilled analyst sample requests by the indicated deadline, and communicating any issues when needed.● Utilized the Tecan liquid handler to aliquot bulk drug substance (BDS) submissions.● Coordinated any external sample shipments to other KBI sites.● Completed any other tasks needed by Tech Leads and Project Management.

Cary, Nc

• Served as the Sample Management liaison both internally and externally for Jaguar’s Process Sciences Lab.• Reviewed quotes to identify Scope of Work Agreements and Purchase Orders needed to complete Sample Submission Forms for sample shipments to contract testing labs.• Prepared and aliquoted sample solutions for internal and external contract testing lab analysis.• Organized and maintained sample inventory to differentiate samples for analysis, samples being shipped and reserved samples utilizing Excel.• Compiled Certificates of Analysis from third-party labs and updated testing results in Excel file for implementation of LabWare LIMS. • Liaised with contract testing lab project management on sample analysis schedules and post analysis data availability.Key Achievements/Contributions• Proposed the use of electronic sample submissions utilizing DocuSign, 21 CFR Part 11.• Increased visibility of internal samples submissions through SharePoint lists, to forecast sample analysis schedules for Analytical Development Scientists

Durham, North Carolina, United States

• One of the most senior members of SM, assists other colleagues with SM process concerns/questions in the absence of the Team Lead.• Efficiently and accurately, accessions 150-200 clinical samples per day, importing into electronic sample management systems (eSMS) Watson LIMS or FreezerPro.• Engages with Project Management regarding sample forecasts, data imports, and discrepancy resolution.• Monitored sample analysis deadlines and expedited TATs.• Identifies and investigates sample discrepancies and correcting sample anomalies with information provided by the study client/sponsor.• Utilizes eSMS to fulfill sample requests, as well as management of pre-test samples given to analysts and post test samples returned to SM.• Routinely maintained operability and remote monitoring of sample storage units using REES monitoring system.• Audited training files of Sample Management personnel ensuring that all annual regulatory trainings were completed and CV/resumes were up to date• Reviewed and as needed, revised SM related SOPs. • Served as a trainer to both new Sample Management Technicians and Specialists.• Duties described as a Sample Management Technician. Key Achievement/Contributions• Creating a formalized training program for new Sample Management personnel including work instructions to use when in the lab.• Created receiving and accessioning processes for GMP and stability samples within Watson LIMS• Coordinated with the QA Archivist manager, to research inactive/completed studies and disposing of approximately 15,000 samples from over 75 studies.• Proposed process changes in shipping samples to include a second check of the number of containers being shipped as well as address verification of the destination.

Durham, North Carolina, United States

• As a Laboratory Technician, receives daily between 35-50 sample shipments from other CROs and clinical sites in the U.S. and globally.• Initiates sample chain of custody, by completing sample receipt documentation, noting sample condition and number of samples received. • Reviews shipment documentation to ensure samples were kept and maintained at the appropriate temperature conditions, throughout the accessioning process and in long term storage.• Using Excel, prepares electronic files for import into eSMS.• Reviews study sample demographic data to confirm consistency between sample labels, study paperwork, and eSMS• Electronically manages and organizes study files regarding sample inventory, and completion of sample accessioning by the testing schedule.• Collects metrics data required to monitor sample management processes.Key Achievements/Contributions• Participated in creation of accessioning procedures for the newly validated Sample Handling module in Watson LIMS. • Served as a trainer for new Sample Management Technicians.• Promoted to Sample Management Specialist

Rtp

• As an MCS, provided telephonic and virtual support to patients, Health Care Professionals (HCPs) and consumers for PPD’s pharmacovigilance/medical communications department.• Received 35-50 calls and emails weekly, pertaining to pharmaceutical product inquiries, adverse event reporting (AER), and product complaints reporting (PCR) from consumers and HCPs. • Created and documented all interactions in IRPC according to PPD, HIPPA and the client's guidelines.• Identified and reported AERS and PCRS within 24 hours of initial contact.• Worked closely with operations management and client contacts to help resolve complex consumer issues such as missed dosing following device failure, device replacement and reimbursement for failed devices.• Maintain knowledge of current policies procedures of both PPD and the client, Standard of Operating Procedures (SOPs), protocols, Good Clinical Practices as well as any new client products.• Researched and disseminated HCP and site information for inquiries related to clinical trials enrollment.Key Achievements/Contributions• Assisted in the creation of job aids for other MCS agents, to answer FAQs and other inquires pertaining to the delayed dosing device• Earned multiple awards for months with no missed AERS and outstanding customer service.

Richmond, Virginia Area

• As a contractor with the state public health laboratory, served as the subject matter expert of Sample Support Services (SSS) procedures in the absence of the Senior Scientist and/or Group Manager.• Contacted submitters to verify missing/erroneous sample information to ensure it meets the parameters for the requested test(s).• Rejected any samples that failed to meet set parameters for specific testing and notified the submitter of this action.• Coordinated kit replacement for bacteriological water samples that were rejected for testing.• Given system permissions to update/correct sample information entered StarLIMS by other employees.• Trained new personnel on laboratory procedures in the accessioning of human health and environmental samples according to established SOPs.• Once achieved, signed off on new personnel technical competency assessments.• Served as the liaison between the DCLS and the sample courier in resolving issues pertaining sample transport, process improvements and invoice reconciliation. • Reviewed and revised technical procedures to reflect current laboratory practices.• Reviewed work of others and documented approval.• Previous duties described of the Laboratory Technician.Key Achievements/Contributions• Saved DCLS approximately $1,100 a month, by researching the routes of the courier and identifying pick up sites that were no longer in operation.• Assisted in the accessioning of Drugs of Abuse samples from the Dept. of Corrections to yield over 300 samples accessioned per hour.• Participated in SSS process improvement procedures using the updated StarLIMS.

Richmond, Va

• As a contractor for the state public health laboratory, was responsible for sorting and processing clinical and environmental samples delivered by courier and sent by mail, following departmental Standard Operational Procedures (SOP).• Sorted and inspected clinical and environmental samples, submission forms and containers to ensure they met parameters for testing. • Ensured sample integrity by maintaining samples at proper temperature conditions.• Daily accessioned 200-300 clinical and environmental samples into Webvision and StarLIMS• Performed data entry of clinical and environmental specimen into the Laboratory Information Management System (LIMS).• Delivered all accessioned samples within 2 hours to analytical laboratories and/or other designated personnel. • Prioritized delegated tasks to work autonomously with minimal supervision from the group manager.Key Achievements/Contributions• Promoted to Scientist I.

Richmond, Virginia

• As a Peer Educator, facilitated peer support group sessions on diabetes management, through health education, nutrition and physical activity.• Assisted in organizing community outreach activities to increase awareness of diabetes as well as promotion of the DART program.• Administered informed consent and health information release forms to access participants’ personal and health data. • Served as the DART program coordinator for volunteer and student interns from local universities.• Maintained participants’ biometrics, progress notes, and demographics in MS Excel and MS Access.• Coordinated monthly support groups and presentations by health/medical professionals for current past program participants.• Screened and assisted qualified program participants with enrollment into medical and prescription subsidy programs.• Revised initial program curriculum to reflect updates in the health information being presented.Key Achievements/Contributions• Through health education, program participants reduced their A1c by 0.5-1%, their total cholesterol count by 60-70 mg/dl and lost on average 5% body fat compared to pre and post program biometrics.• Recidivism in the program dropped to 30% with successful participants engaging in the monthly support meetings and/or sought extended case management from the nurse case managers.

Associate Of Science - As, Clinical Trials Research Associate

Activities and Societies: Phi Theta Kappa Honor SocietyThe Clinical Trials Research Associate curriculum prepares individuals to assist.

Certificate, Clinical Trials Research Associate-Core Competencies

Activities and Societies: Phi Theta Kappa Honor Society Completed with honors (Cum Laude)

Bachelor'S Degree, Health Sciences

Activities and Societies: JMU Women's Track and Field Team, Zeta Phi Beta Sorority, Inc.-Theta Nu Chapter, Community Caregivers Program.