Danielle Gries Email & Phone Number

Phoenix, Az, Us

Remote

• Site identification tasks: CDA negotiation and execution, site survey/questionnaire completion, feasibility discussion, PI listings/ debarment review, essential document collection, greenlight • Reviews essential documents from sites to ensure all required documents are accurate and complete to compile project-related activation packages, IP release, regulatory submission• Lead site start-up meetings with sponsors to present weekly status updates• Facilitate the study development process including start-up, enrollment, and close-out• Management of study budgets, vendors, invoicing, purchase orders, and requisitions• Tracks clinical trial progress, identifies operations issues and escalates issues to the attention of the Project Manager• Communicate with Sponsor representatives and internal project team on site and study timeline updates• Develop training tools for the study personnel, vendors, and investigator sites• Coordinates and partners with Project Managers and Functional Leads to oversee set-up, maintenance, inspection readiness, and archival of Trial Master File• Supports contract and budget negotiations with sites• Facilitates the coordination of study training meetings• Mentoring and training junior staff

Madison, Wisconsin, United States

• Conduct various management tasks including annual performance reviews, goal setting for career growth and development, delegation of department workload and selection and on-boarding of new employees. • Collaborate with project managers to create project plans, conduct study meetings, maintain timelines, to provide on time deliverables to clients for up to 20 ongoing clinical trials. • Improved payment tracker for multiple site studies to expedite payment processes.• Communicate effectively with clients to ensure study expectations are maintained. • Own project plan creation and development for client approval.• Liaise with cross-functional teams to ensure essential study timelines and communications are maintained. • Lead work stream to implement change of a new department wide site payments process to simplify site payments for project coordinators and expedite processed payments back to the site. • Maintain ongoing training and support for PC team by holding weekly open forum sessions and creating job aids for later reference. • Maintain project timelines in MS Project for ongoing studies to track deliverable deadlines.• Global Board Member for Young Professional Career Development Employee Resource Group.• Manage and maintain study budget and invoicing for multi-site studies.• Correspond with site leadership to determine feasibility of contracting study based on protocol requirements. • Maintain regulatory requirements and submissions throughout the study. • Train project managers and directors on new processes and software.• Maintain up to date study systems including CTMS and eTMF in Veeva Vault.• Oversee Site Start-Up activities to ensure regulatory aspects of study are met and screening begins timely.

Madison, Wisconsin Area

Managed activities for clinical studies in phase one clinical pharmacology. Lead site start-up team to ensure team and documents stay on track. Collaborated with global sites to determine feasibility of trial and green-light the sites for IP shipment and subject enrollment. Managed and distributed project meeting minutes during weekly client meetings.Responsible for maintenance of eTMF throughout study. Trained in special studies including impairment and tobacco. Client specific trained to be a subject matter expert and trained new employees. Maintained and updated project timelines. Managed of project specific training for all team members.Managed site and subject payments in CTMS to ensure trial stays below client budget. Collaborated with the IRB for continuous review and approval for duration of study. Assisted with site contract and budget negotiations during site on-boarding. Lead contact for external sites for duration of trial, site’s liaison for IRB, client, and payment communication.

Madison, Wisconsin, United States

Managed activities for clinical studies in phase one clinical pharmacology. Lead site start-up team to ensure team and documents stay on track. Collaborated with global sites to determine feasibility of trial and green-light the sites for IP shipment and subject enrollment. Managed and distributed project meeting minutes during weekly client meetings.Responsible for maintenance of eTMF throughout study. Trained in special studies including impairment and tobacco. Client specific trained to be a subject matter expert and trained new employees. Maintained and updated project timelines. Managed of project specific training for all team members.Managed site and subject payments in CTMS to ensure trial stays below client budget. Collaborated with the IRB for continuous review and approval for duration of study. Assisted with site contract and budget negotiations during site on-boarding. Lead contact for external sites for duration of trial, site’s liaison for IRB, client, and payment communication.

Madison, Wisconsin

• Organized all operational aspects for patients during clinical trials from screening to follow-up visits. • Coordinated multiple patients on different time points on 20 different studies. • Created and implemented new process to track pharmacist approved con-meds to avoid duplicate requests. • Collaborated with cross-functional teams to adhere to protocols and ensure patient safety. • Primary liaison for patients during clinical trial.• Provide weekly patient status reports and updates to clinical research disease oriented team. • Educated patients on important risks and benefits of clinical trials before obtaining consent to participate.• Developed study specific documents for use in data collection.• Assisted in auditing internal data.• Utilized Epic Software to maintain patient data and medical records.

Winston Salem, North Carolina

• CITI certifications in Good Clinical Practices, Institutional Review Board, and Biomedical Science. • Assisted investigators in regulatory aspects of clinical research including writing consent forms.• Improved data collection by creating Excel spreadsheets with equations to effectively organize very large subject datasets.• Created research forum for medical center wide research trainings, discussions, and speakers.

Winston Salem, North Carolina

Assisted in Immunology and Cancer Biology labs on current research.Cell culture, flow cytometry, cell separation, neonate vaccine development. Separated spleenocytes to isolate B- cells. B- cells were then stimulated with different vaccines and adjuvants to test for best immune system response. Performed histology work on ovarian and bladder tumor tissues.Cryostat and OCT sectioning.Antibody staining .

Madison

Preformed histology and necropsy tasks while following Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs), and protocol guidelines.Proficient in histology related tasks including, trimming fixed tissues, embedding processed tissues in paraffin and sectioning blocks for slides. Participated in research for early development of new pharmaceutical drugs.Worked efficiently as a team to deliver quality slides to clients on time.Awarded 10 “ACE” (Achieving Covance Excellence) awards in 8 months for going above and beyond expectations.Created schedules for department based on necropsy workload.Ergonomic Team: committee designed to improve lab techniques to prevent strain and injury from poor posture and repetitive motion in the labs.Member of Spill Response Team to ensure safe cleanup of spills throughout the building.Chosen to mentor new employees and help adapt to new fast pace environment.Trained to trim and embed ocular specialty tissues.

Madison, Wisconsin Area

Assisted graduate students with current limnology research. Collected water samples from Lake Mendota using a tow net to collect populations of spiny water flea. Developed multiple methods to discover the population density of spiny water flea in the lake. Collected samples of water from multiple vessels of the boat to discover the methods of spread of invasive species to other waterways in Wisconsin. Created research project for senior thesis. Presented at University wide poster session.

Madison, Wisconsin Area

Mentored 66 first year students in adapting to college life and academics. Assisted in conflict resolution for roommate conflicts.Promoted academic excellence.Assisted in selection, evaluation, and training of incoming house fellows. Successfully organized 4 events per month while maintaining a budget, supporting housing requirements, and resident desires.Attended diversity and leadership trainings to create a safe living environment.Facilitated monthly meetings to inform residents of new policies, important updates and events.Delegated residents as “floor representatives” to assist in communicating information.

Appleton, Wi

Provided excellent customer service to ensure customers had an enjoyable, dining experience. Organized gift shop and did inventory. Trained new employees according to company standards. Helped cater special events.

Madison, Wisconsin Area

Researched possibility of adding fall break to the academic calendar of UW- Madison. Created campus wide survey to gain support and poll the opinion of the student body. Met with campus health officials to determine if break would help the mental health of students. Met with professors to gain support and have a non-student voice. Gained support for project from Dean of Students.

Bachelor Of Science (B.S.), Biology

Activities and Societies: Associated Students of Madison, UW- Madison Housing Residence Life, Intramural Sports

Master Of Biomedical Science, Molecular And Cellular Biosciences

Activities and Societies: Student Wellness Committee, Intramural Basketball