Kira Grist Email & Phone Number

Kenly, Nc, Us

Connected Devices is one of the most dynamic and interesting areas within the Clinical Research industry. The identification, strategy and management of various devices and their data ingestion modalities in order to meet the endpoint goals of our customers is ever challenging and exciting. This highly visible business unit is closely connected to other trial delivery teams within IQVIA. We work closely with technology partners and our sponsor partners to help speed therapies to market in a global network.As an Associate Project Manager, I manage small to medium size Connected Devices projects that are stand-alone or full-service in scope, across all phases of clinical studies. I ensure that all project work is completed to the sponsor's satisfaction, on time and within budget and in accordance with policies and procedures.

Virigina Beach, Va

As a member of Beaufort's global project team, I direct and coordinate the staff and resources needed to successfully manage clinical research studies that align with sponsor objectives, timelines, and budgets. I oversee all activities related to project management, clinical protocol and SOP training, site initiation and management, site monitoring, and project report development for internal stakeholders and clients. Beaufort is a global CRO built around one purpose — helping life science companies improve and save lives through the rapid development and commercialization of innovative products. Our shared interest and commitment to your success drive our entire organization to deliver best-in-class clinical trial services, regulatory strategy and planning, data and business analytics, data management and statistics, and quality services.

Virginia Beach, Virginia, United States

As a member of Beaufort's global project team, I perform a wide variety of clinical trial site activities that maximize performance while ensuring data quality and site compliance with protocols, SOPs, and regulatory guidelines. I work directly with investigators and site staff, perform site qualification, initiation, and monitoring visits, monitor patient recruitment timelines, conduct data verification, and generate reports as needed for internal stakeholders and clients.Beaufort is a global CRO built around one purpose — helping life science companies improve and save lives through the rapid development and commercialization of innovative products. Our shared interest and commitment to your success drive our entire organization to deliver best-in-class clinical trial services, regulatory strategy and planning, data and business analytics, data management and statistics, and quality services.

Morrisville, North Carolina, United States

• Facilitate initial conversations regarding scope, timelines, costs, and risk during both the internal and external kick off meeting for new studies while ensuring effective communication regarding the clinical study between the principal investigator(s), sponsor, and testing personnel.• Enable the effective delivery of the services provided as it relates to the Companion Diagnostic (CDx) and In-Vitro Diagnostic (IVD) Studies in Q2 Laboratories globally.• Lead internal efforts during project initiation to define the resources and timelines needed o Responsible in identifying and managing project tasks, mitigating and managing risks, and raising concerns to the client and internal team as appropriate.• Collaborate with project team throughout the study to understand and resolve issues as needed• Ensuring that proper follow-up for and audit finding actions are completed by the necessary parties (PI, Lab Staff, QA, etc.).

Morrisville, Nc

-Ensure that any processes and the testing involved is properly documented and available for review by the sponsors and any regulatory authorities-Regulatory study binder generation and maintenance and all related documentation in compliance with good documentation practices-Verifying all documentation is completed/filed appropriately including sponsor communications, including: audit or site visit findings, investigations and CAPAs (as needed) are filed in the binder-Coordinate/facilitate site visits and audits with the project manager, principal investigator and the sponsor-Hosting IVD/CDx site initiation, monitoring and close out visits and documenting as well as ensuring the close out of corrective actions as identified

Morrisville, North Carolina, United States

- Worked with a small team to set up a sister lab in Beijing China, including reagent shipping documentation, equipment validation plan paperwork, assay qualification initiation and traveled overseas to help oversee the set up and organization of the new lab.- Work with Research and Development team to transition new assays and technologies into the group and improve the integration of these new assays into production.- Working on client specific projects including reproducibility studies and validation work- Responsible for training new employees and ensuring individual competence on various assays, including understanding GLP expectations and verifying training runs are consistent with team/company expectations.- Competent with multiple laboratory methods including extraction of nucleic acids from tissue and cells, sample QC, purifications, automation, library preparation and Next-Generation Sequencing Platforms- Update, streamline and revise assay methods to be more efficient, yield higher quality samples and result in more consistency between users on the isolation and sequencing team.- Experience on multiple regulated studies, including sample verification, isolations, sample quantification, library preparation and through sequencing and data entry and perform/document all specimen test procedures with accuracy, consistency, and timeliness in accordance with current standard operating procedures and regulatory guidelines.

Durham, Nc

o Genomic isolation of various tissue types and cells o Perform nanodrop and run bioanalyzer chips for RNA and DNA samples in addition to preparing and completing process testing records for the sampleso Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelineso Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that the results are within acceptable tolerances o Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to senior lab personnel

Morrisville, Nc

• Participated in clinical studies that implement standard operating procedures and good laboratory practices.• Read, analyzed, and assisted in preparing for clinical studies by designing charts, experiment timetables and paperwork while ensuring materials necessary for projects were on site before study initiation.• Responsible for archiving completed studies by ensuring that all pertinent information was organized and documented according to standard operating procedures and good laboratory practices guidelines.

Crop Science, Dr. Ralph Dewey

o Work to identify tobacco lines with homozygous knockout mutations at CYP82E4, CYP82E5 and CYP82E10 loci by collecting samples from each plant and extracting DNA for use in genotypingo Furthered education through experience and gained a deeper understanding of how various processes were carried out and why • Became proficient with multi-channel pipettes • Developed a more effective method to organize samples to make genotyping more efficient and easier to analyzeo Taught how to problem solve when genotyping did not work properly and learned how to effectively trace mistakes back to the source of the problemo Manage time wisely to ensure that tasks are completed in a timely manner while balancing school demandso Learned to coordinate various procedures in order to be as efficient with time as possibleo Became effective at completing multiple tasks at the same time

Raleigh-Durham, North Carolina Area

o Successfully created a vector containing the Flowering Locus T (FT) gene, incorporated into a PVX Expression System and applied the genetically modified virus to various tobacco lines to decrease flowering time, thus decreasing the time required for backcross breeding in tobacco cultivarso Assisted in the Harm Reduction Project with the collection of leaf tissues, placing the designated samples into cluster tubes and performing DNA Extractions for genotyping for a specific genetically modified cultivaro Aimed to identify plants that had homozygous knockout mutations at CYP82E4, CYP82E5 and CYP82E10 loci which significantly decreases the nicotine conversion into the carcinogens present in cigaretteso Learned a multitude of skills and techniques for a variety of procedures such as: performing DNA purifications, utilization of nanodroppers and centrifuges, enzymatic digestions, ligations, transformation and insertion of vectors into E. coli and Agrobacterium tumefaciens, using gel electrophoresis, T-streaking for cultures, western blots and PCR reactionso Used time effectively to ensure that all tasks were completed on time to keep the project within a designated time period and planned ahead to make sure that all procedures could be carried out as efficiently as possible

Johnston County, Nc

o Strived to show children the value of respect, responsibility, honesty, caring, and faith in God through games, crafts and songso As Head Counselor, responsible for organizing other counselors, allocating work duties and running the siteo Learned to interact effectively with both children and parents to further child’s education and character developmento Played leadership role and promoted good behavior by being a positive role model and utilizing positive reinforcement

Bachelor'S Of Science, Biological Science

Minor, Genetics