Nancy Gee Email & Phone Number

Boston, Ma, Us

-Responsible for execution and management of clinical trials-Provide oversight and guidance to clinical operations teams, documents, and processes to ensure patient risk-benefit is optimized-Report statuses of program milestones and escalate issues to appropriate Leads. -Identify program risks and develop and manage mitigation plans-Develop and maintain productive partnerships with internal and external stakeholders including communication plans and setting of program milestones-Maintain a positive culture and strong working relationships across organizational functions-Develop and updated integrated program timelines and budgets through collaboration with internal and external stakeholders as required to support operational plan-Develop operational plans to ensure compliance to current regulatory guidance and GCPs-Collaborate with investigators to design, develop, implement and conduct their FDA/NIH and industry funded clinical research studies.-Contribute to the writing and review of clinical documents such as protocols, informed consents, monitoring plans, study reports, and annual preports-Develop study-specific data management and quality assurance procedures and monitor implementation.

Boston, Ma, Us

-Study manager/coordinator for several complex multi-site research studies and trials-Collaborate with investigators to design, develop, implement and conduct their FDA and privately funded clinical research studies.-Collaborate with investigators to develop, write, and submit grants and study protocols.-Develop and implement study-specific data management and quality assurance procedures-Lead and collaborate with department data managers and statisticians to design and develop study databases and related products and procedures for each clinical research protocol-Function as department liaison for laboratories, imaging, grants and contracts, IRB, and billing-Develop trainings on hospital and research guidelines-Provide indirect management of 20+ study coordinators/research assistants

Watertown, Ma, Us

Responsible for overseeing all aspects of project management for four-NIH funded trials, including study start-up and close-outResponsible for training site personnel on protocols and development, testing, and validation of electronic case report forms (CRFs)Develop and maintain the Manual of Operations (MOO)Function as project liaison for core laboratoryProcess, track, maintain and file submissions to the IRBAdvise principal investigators, research staff, IRB chair and members, and institutional officialsDevelop, revise and implement NIH, FDA, and NERI policies and proceduresProvide and oversee Human Subjects Protection educationCoordinate the submission of project reviewsEnsure the timely delivery of reports to various monitoring committees

Watertown, Ma, Us

Responsible for overseeing all aspects of project management for four-NIH funded trials, including study start-up and close-outResponsible for training site personnel on protocols and development, testing, and validation of electronic case report forms (CRFs)Responsible for monitoring regulatory data and notifying sites of expirations, missing documents and information discrepanciesProcess, track, maintain and file submissions to the IRBAdvise principal investigators, research staff, IRB chair and members, and institutional officialsDevelop, revise and implement NIH, FDA, and NERI policies and proceduresProvide and oversee Human Subjects Protection educationCoordinate the submission of project reviews

Watertown, Ma, Us

Responsible for monitoring regulatory data and notifying sites of expirations, missing documents and information discrepancies; Process, track, maintain and file submissions to the IRB; Certify and train Study Coordinators and IRB members;Assist with pre and post grant and manuscript preparation; Serve as IRB interface with subjects, investigators and sponsors; Participate and review new and existing proposals/protocols as IRB voting member

Watertown, Ma, Us

Responsible for overseeing all aspects of data management for two NIH-funded Phase II and Phase III trials, including preparation of instruments, developing coding manuals, preparing instruments for programming, testing programs, supervising editing and data entry, quality control, data cleaning and analysisInterfaced with site personnel regarding solutions to various data management issues and conducted monthly conference calls to monitor data management activitiesPrepared Steering Committee and Data Safety Monitoring Board reportsTaught NERI wide Data Management training classes

Watertown, Ma, Us

Developed and tested paper and electronic CRFs and integrity edit checksGenerated, distributed and resolved queriesFormulated and revising study-specific and corporate standard SOP manualsAssisted in the development of MOOs; created user guidesPerformed data entry of CRFs; Developed and maintained internal tracking databasesRevised and updated study protocolsTrained data management personnelAdministered training intervention for SBIR studyImplemented and certified guidelines for research assistants to facilitate data cleaning and problem resolution

Watertown, Ma, Us

Performed initial and double-data entry of CRFsGenerated, distributed and resolved queriesProvided external support to user-identified system errorsFunctioned as liaison between project staff and programmerDeveloped user guides and training materialsCompiled data for monthly progress reports for the project team

Masters Of Public Health, Epidemiology

Bs, Sociology