Annie Mills Email and Phone Number

*Conduct global clinical trials and registries according to applicable regulations*Prepare essential documents according to ISO 14155 and FDA regulations*Plan and track the progress for clinical trials, including developing and implementing tracking tools and strategies*Oversee and manage subcontractors*Liaise with study investigators, site personnel, and internal team members*Collect and review clinical data for MDR, FDA and other reports as needed*Lead and conduct team meetings

•Responsible for independently performing site training, regulatory document collection, tracking enrollment, and ensuring case report forms are accurate, complete, and verifiable against source documents. Help to prepare and conduct site initiation, interim and close out visits.• Contributes to the development and improvement of company procedures, processes, and templates, including the development of site recruitment and retention strategies. •Assist in development of protocol/ ICF / CRF / CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools. • Develop and maintain site and study level tools and tracking templates to assess study level metrics.•Assist sites to resolve regulatory document issues. Ensure adequate study and regulatory documentation is maintained at the both the investigator site and the sponsor eTMF. •Verify appropriate reporting and documentation of adverse events, device deficiencies, protocol deviations and enrollment metrics. Document and report non-compliance in a timely manner. Identify areas requiring follow-up and improvement at each clinical site, recommend corrective action and or conduct site re-training as needed. Ensures closure of open actions.•Provides training and guidance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation, and other monitoring activities.

*Supports Project Team with the management of research studies from study initiation throughclose-out activities with emphasis on teamwork, quality, timelines, budget, metrics andcompliance with the project plans and SOPs.*Develop the strategy, plans, tools and training to oversee and assess performance of the clinicalteam, in the conduct and compliance of site visits (on site and remote), including: SiteQualification, Site Initiation, Interim Monitoring (remote and/or on-site) and Study Close-outActivities, and Audit Support Visits. *Proactively communicate with CRAs and other members of the clinical operations team to followup on all open issues, drive patient recruitment and retention, in order to meet the projecttimelines.*Responsible and accountable for understanding and managing the clinical operations budget forthe project and ensure that the activities are within budget and scope of work, and to discuss withthe project team to support financial progress, and team utilization.*Communicate effectively with all members of the project team and client as applicable, to supportthe study completion per company and client requirements and timelines, including riskidentification and mitigation, issue escalation and working with Quality and the project team onCorrective and Preventative Actions.*Preparation for Safety Management Review meetings (e.g., episode review, agenda preparation,and meeting minutes).*Responsible for the maintenance of study specific files and documentation.

• Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.• Support project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study and discuss potential study risks and opportunities with the Project Manager and CTL.• Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.• Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).• Perform CRF review, query generation and resolution against established data review guidelines, Covance or client data management systems, as assigned by management.• General On-Site Monitoring Responsibilities: PSVs, SIVs, RMVs and COVs, and act as a co-monitor for on-site RMVs as needed.• Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, including remote monitoring that includes SDV when sites provide remote access to their EMR.• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.• Mange sites to ensure subjects are complying with protocol requirements, study visits, and timelines.• Serve as a mentor to less experienced In-House CRA staff.

• Supports Project Teams with the management of research studies from study initiation through close-out activities (informed consent development, data and query management and investigational site management). • IRB/EC management including site application assistance and approval tracking.• Responsible for the compilation and maintenance of site regulatory documentation.• Adheres to good clinical practices, study protocols, and applicable regulations. • Preparation of study progress reports for project team and sponsor.• Preparation for safety management review meetings (e.g., binders, agenda preparation, and meeting minutes).• Performs site qualification, site initiation, interim monitoring (remote and/or on-site) and study close-out activities of study centers for compliance with clinical protocol and applicable regulations.• Responsible for the maintenance of study specific files and documentation.• Reviews and manages clinical site payments.• Authorized to have direct communication with the clinical study sites and conduct daily activities supporting the study/project.• Ensures reported trial data are accurate and complete, and participates in clinical data processes, as needed.

• Implement research protocols (including maintaining compliance with all federal and local agencies in accordance with GCP guidelines)• Work with patients and families for obtaining informed consent, scheduling research visits, conducting clinical research visits, and collection of data• Data collection and entry processes utilizing various EDC platforms• Manage all study-related communications with investigators, regulatory bodies, site monitors and study participants• Prepare regulatory submissions to the Institutional Review Board, and maintain compliance with all federal and local agencies in accordance with GCP guidelines

•Assist in the development of grant applications for studies examining the most effective cessation methodologies for tobacco products•Recruit and screen potential study subjects, following all HIPPA regulations •Administer study procedures to qualified subjects•Maintain data files for all study subjects, in compliance with HIPPA regulations•Engage in correspondence with the IRB to ensure proper study procedures and regulations are being followed•Training and supervision other study staff

•Co-lead group counseling sessions aimed at encouraging and motivating study participants to quit smoking•Independently facilitate group exercise and relaxation sessions to study participants •Encourage participants to engage in exercise and relaxation practices outside of group sessions to combat smoking urges •Assess and evaluate participants progress on exercise and relaxation goals•Routinely gather physical and psychological data on study participants •Data entry using Microsoft Access

•Provide gait analysis to ensure that customers purchase the correct type of running shoe•Provide training tips, racing strategies, running plans and motivation tips to inspire customers to reach their running goals•Explain the proper use of all store products including watches and GPS systems, injury treatment tools, nutritional aids and supplements, and specialty apparel •Monitor and place orders for gear and nutritional supplement inventory•Train new staff members

•Assess client diet and exercise goals to develop individualized training programs•Guide clients through individualized workout routines, correcting form and administering feedback•Check in with clients on a regular basis to ensure adherence to personalized fitness plans and answer any questions and concerns of the client

•Review personal health assessments with participants •Explain appropriate ranges for health values such as blood pressure, cholesterol and BMI •Recommend and register participants for appropriate health programs based on results of personal health assessments

•Answer inbound calls and provide assistance to participants who call in regard to Staywell health programs•Ensure HIPPA policies and procedures are followed correctly to maintain participant PHI confidentiality•Make recommendations and register participants for appropriate Staywell Health programs•Work in a team environment with other helpline representatives, health advisors and health coaches to ensure high quality customer service

•Provide individual counseling and support to residents•Lead individual and group activities such as crafts, meal preparations, and fitness activities•Collaborate in facilitating group therapy and treatment planning with other members of the staff including licensed psychologists and psychiatrists

• Performed behavioral tests on drug addiction and discrimination in operant conditioned non-human primates• Assessed treatment strategies for stimulant dependence• Examined possible therapeutics effects of novel monoamine releasers in drug-food choice experiments• Manipulated testing paradigms and modified choice between drug and food reinforces to evaluate stimulant abuse potential• Managed supply ordering