Sara Dinkins Email and Phone Number

• Oversees, designs, plans and develops clinical evaluation research studies.• Prepares and authors protocols and patient record forms.• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.• Responsible for clinical site and vendor selection.• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.• Drives local evidence dissemination & awareness.

.•Provides project and program support to a functional group.•Monitors program/project/system status, budgets and timetables.•Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures.•Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding.

Site Relationships:• Arrange and perform all tasks required for onsite/remote monitoring including: source document review and verification, database review and verification, query resolution, training site research personnel, and investigator interactions.• Support research sites with preparation and submission to Institutional Review Boards (IRBs).• Generate and execute site payments while adhering to study budgets.• Manage compliance with requirements of the protocol, informed consent process, data collection, and subject enrollment activities.Trial Management:• Ownership of the accuracy and completeness of the Sponsor Trial Master File.• Develop clinical study documents including study protocol, informed consent forms, case report forms, and patient reported outcomes.• Spearhead subject recruitment, enrollment, and retention activities by tracking patient status, distributing subject stipends, and overseeing the coordination of subject travel.• Manage vendor relationships, monitor compliance with study metrics and deadlines, and execute invoicing.• Seamlessly interfaces with multiple EDC environments for monitoring site-level and attribute-level details.• Creation and dissemination of reports on study and site health, synthesized final adverse event outcomes and rankings, and regulated annual reporting. KOL Relationships:• Liaise with Surgeon Development teams regarding study products and procedures.• Interface with Surgeon research consultants on study development and monitoring activities.• Develop and manage Adverse Event Committee review packages and meetings.

Experienced Institutional Review Board Panel Coordinator on both Full Board and Expedited panels with specialization in annual protocol reviews and amendments. While working at the university, I was responsible for redesigning the processing of annual reviews of protocols to ensure protocol prioritization to avoid expiration of time sensitive submissions. Key responsibilities included collaborating with team members to assure team success while managing multiple time sensitive IRB submissions and built relationships with investigators, board members, and affiliated research personnel. Highly skilled in researching and interpreting Federal, State, and institutional requirements pertaining to human subject research and maintain appropriate compliance documentation.• Responsible for training new IRB staff on research database software.• Analyzed reports of non-compliant protocols for outside regulatory agencies review and audit.• Audited study files to ensure the contents were accurate, complete, and consistent with the database and protocol for quality assurance purposes, FDA, and OHRP visits and audits.• Evaluate unanticipated problems and adverse event reports and serve as an advisor to the IRB Chairs and members at monthly IRB meetings.• Analyzed technical research, medical and legal language, and research concepts, synthesizing the essential points from complex multi-participant discussion.• Resource for investigators to certify complete submissions and completion of requirements.• Planned, coordinated, and staffed a committee to perform timely reviews of clinical studies, and other electronic IRB submissions for compliance with research protection regulations. • Managed records documenting and disseminating the decisions and requirements of the review board in compliance with institutional policies and applicable federal regulations.

• Responsibilities included maintaining a positive and safe environment while remaining current on educational standards, requirements, and licensing.• Created and executed curriculum tailored to children’s individual and group needs.• Worked with fellow teachers to build and maintain positive, trusting relationships with families.• Understood and developed different dynamics with children based on the individual child’s needs.• Maintained certifications required to remain compliant with state and federal laws.

• Responsibilities included proctoring and grading exams, grading and recording papers and assignments, and managing grade book.• Handled, trained, and cared for animals used in classroom labs.• Online teaching responsibilities included fostering discussion among students, grading and recording assignments, and assisting students.• Provided needed mentorship, assistance, and guidance for all students.• Developed, designed, and executed meticulously researched experimental thesis.

• Acted as an on-air reader of material unavailable in large print or braille for those visually disabled, physically disabled, and/or blind.• Other duties included setting up and editing recordings, managing audio data and the recording systems.• Supervised volunteer readers.