Mary Moss, Mph Email & Phone Number

United States

Responsible for management of the source documentation process, acts as a back-up manager for the Operational Excellence Team.•Creates workflows and work instructions for various processes within the company•Assists in organizing Site Support and some larger Site Operations meetings•Manages trial source creation through collaboration with Project Management•Manages helpdesk ticket requests for source documentationAssists in the implementation of an eSource platform

Subject Matter Expert for source documentation and ALCOA+C standards, responsible for the management of the source documentation team and activities.•Collaborated with sites to develop emergency plans•Created manuals and training videos for my team and site operations•Extensive troubleshooting in eSource platform

Responsible for generating electronic source documentation in CRIO that complies with SOP, regulations, and study documents provided by the Sponsor in a timely manner while ensuring quality documents for sites to conduct study visits.•Perform quality review of source documents that are created by other Source Documentation Specialists or Clinical Trial Navigators•Updated source for protocol amendments and as needed by Clinical Trial Navigator, Investigator, Quality Assurance reviewer, sponsor/CRO or healthcare partner•Collaborate with the Finance Team to ensure that the budget is set up correctly for the source documents before activating it for use•Validate electronic source documentation by creating a validation test patient and completing every visit to verify that all required data is captured appropriately and accurately•Mentor others on source document creation

Responsible for feasibility data analysis to determine sites that would perform well on various trials, supporting sites pipeline needs, and promoting PMG Research's mission with Sponsors and CROs.• Orchestrate central feasibility requests for multiple sites in a timely manner and prepare proposals for clients.• Interact with site managers and investigators to provide support in meeting their needs with future trials.• Develop presentations to enhance site performance and efficiency.• Manage feasibility requests and historical data in CTMS system.• Identify and perform outreach for business development opportunities within therapeutic areas.

Follows sponsor protocols, SOPs and PMG CoGs to create thorough source documents for multiple PMG sites. Performs quality assurance reviews on team members' source documents to ensure accuracy of documents.• Proven ability to meet deadlines prior to First Patient First Visits.• Increase requests for source documents at company by creating quality documents for coordinators.• Experience in management of multiple protocols at one time.• Demonstrates flexibility by assisting company sites with various assignments.• Effectively communicate the status of protocols with manager and team members.

Facilitated clinical trials through Good Clinical Practices, SOPs and protocols to ensure compliance and patient safety. Developed relationships with patients to deliver care and create interest in working with our site on future trials. Maintained studies and resolved discrepancies in data with EDC systems. • Mentored new clinical research coordinators on daily tasks.• Achieved enrollment goals for quick-enrolling vaccine trials through team leadership.• Retained more patients for trials at Cary site through creative advertising.

Developed the skills to perform phlebotomy, laboratory processing, blood pressure and electrocardiograms on patients. Executed new clinical trials in addition to managing clinical trials that were already in progress.• Established relationships with monitors, sponsors and investigators to facilitate trials and develop leads for future studies.• Successfully managed daily activities between patients, monitor needs, processing laboratory samples, recruiting patients and various other tasks on a daily basis.• Gained knowledge of medical terminology through various clinical trials.

Rtp, Nc

Responsible for assisting the National Program Director with projects, research and meetings to help manage the program.*Reviewed national programs for the Healthy and Sustainable Communities division*Attended meetings on breast cancer and maternal/child health*Organized and gathered grant information for program

Responsible for assisting in the creation of strategies to reach target population, compiling demographic data for target populations, researching intervention programs, conducting fitness assessments and establishing collaborations.• Represent Be Active at health fairs and other events, to educate people on Be Active’s mission and available services.• Participate in windshield tours and focus groups, to gain a better understanding of the needs of the community.• Improve and maintain the A Matter of Balance web pages on the NC Roadmap website, to create user friendly web pages with up to date information.• Generate flyers with the use of Microsoft Publisher, to educate target populations on healthy habits.

Responsible for stability inventory management, tasks included initiating studies, stability submissions and shipments, annual inventory, maintaining chambers, and removing inventory for stability closures.• Updated critical components in iLIMS software, reducing the time spent on stability report generation.• Reconciled QA Stability Review project which consisted of data from 2006 to 2009, meeting the commitment to upper management.• Created and implemented a manual Quality Assurance Stability Management program, reducing time spent on corrections in iLIMS software and on reports.• Created and revised standard operating procedures (SOPs).

Responsible for generating Certificates of Analysis for Cell Paste lots, stability submissions, stability inventory, Quality Control metrics, participating in audits, maintaining files and Access databases, generating stability protocols and stability reports. • Organized and implemented training on various databases and software, to increase the number of cross trained co-workers to perform tasks.• Generated retain disposal lists, notified client, pulled associated forms and retains to maintain and control retain inventory.• Organized teambuilding for group and served as a member of Company Activities Committee, to create a cohesive atmosphere for co-workers.• Facilitated laboratory renovations and movement of sensitive equipment, to increase efficiency.

Responsible for maintaining environmental monitoring/water databases, creating quarterly and yearly reports of environmental monitoring and water data for trend analysis.• Restructured and streamlined purchasing process for Quality Control Department, reducing the amount of rush orders that Quality Control Groups were placing which saved the Department money.• Led project to set up webpage for the Quality Control Department (FrontPage), which allowed other departments as well as Quality Control the opportunity to access key information about the different groups to improve communication and efficiency.• Interfaced with clients and manufacturers in order to create a reference library for reagent protocols.• Trained co-workers on the purchasing process and using the data entry process.

Responsible for creating PowerPoint presentations, MS Word documents, and MS Excel spreadsheets.•Formed Access database for project contacts and maintained records.•Edited and proofread client documentation.•Assisted in annual business tax preparation

Responsible for managing a 22-extension phone system and supplies inventory.• Tracked Accounts Receivable and assisted partners with schedule tracking.• Maintained client communication within Practice Solutions, MS Excel, and MS Word.• Led office structure reorganization effort to improve use of common workspace.• Assembled individual tax returns and financial statements.

Masters, Public Health In Community Health Education

Activities and Societies: SOPHE Member, Certified in Public Health by the National Board of Public Health Examiners, Certified Health.

Bachelor Of Science, Psychology, Minor In General Management