Judith Pride Email & Phone Number

Remote

Responsible for regional/country level activities from study start-up through conduct and study close out. Accountable for overseeing and maintaining country deliverables as part of the overall project plan. Manages and maintains accurate country level plans. Ensures timely communication bidirectionally between the global and local study team. Drives recruitment and data cleaning at regional/country level. Responsible for report and issue review for reports/issues written by the Site Care Partner. Responsible for local country vendor management. Exceptional knowledge in managing and coordinating specific study management tasks at the country level. Is the Leader of the Regional/Country Operational Sub-Team.

Remote

Main Pfizer point of contact for investigative sites; accountable for site start up activities through actiation and for building and retaining investigator site relationships. Accountable for ensuring sites receive necessary support and engagement, issues are resolved and supports Pfizer’s reputation in being the Partner of Chooice as the “face of Pfizer.” Identifies and recommends sites, leads effective site recruitment, planning, consistent with global or country plan and local targets. Conduct study start up activities at the site including Pre-trial Assessment and Site Initiation Visits and manage issues that might compromise time to site activation. Partners with CRO/CRA to ensure site activation and support site monitoring readiness in anticipation of first subject, first visit. Leads effective site recruitment planning consistent with global/country plan and local targets. Provide enrollment support and ensure progress by responding to recruitment issues from investigators. Supports sites through close out including through escalated issues. Operational point of contact for all site level questions liasing with and escalating to appropriate teams to respond. Informs and educates investigator sites of Pfizer pipeline opportunities , supports development and delivery of decentralized capabilities at sites. Provides country, regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical affairs.

Springfield, Massachusetts Area

Provides oversight, leadership and guidance in the management and execution of clinical research studies. Works collaboratively with Directors in the Office of Research to define and develop the research strategy at Baystate Health. Explores new study opportunities by engaging new investigators to expand and diversify their clinical trial portfolio. Mentors new investigators and study staff throughout the study life cycle. Develops and maintains CRO, pharmaceutical and clinical site relationships. Establishes and maintains policies and standard operating procedures for research operations to ensure compliance with federal, state, local regulations, Baystate policies and Good Clinical Practice. Assists with pre study planning including feasibility, logistics, subject recruitment strategies and attendance at site selection visits. Builds and manages a team of highly skilled research professionals. Works directly with research assistants, coordinators and investigators to realize recruitment and daily management of research participants. Develops and oversees onboarding educational process for new CTO staff.

Springfield, Massachusetts Area

Performs quality assurance monitoring of research protocols and IRB activities to ensure that the conduct and oversight of human subject’s research is in compliance with regulations and in accordance with professional standards. Develops and implements training and educational programs for investigators, research staff and the Institutional Review Boards (IRB). Serves as a resource by providing mentoring and targeted support to investigators, IRB chairs, members and staff in the development, implementation and oversight of research

Advocates and promotes clinical research performed by the Department of Heart and Vascular Services at Baystate Medical Center. Work with sponsors and principal investigators to assess clinical research trial feasibility at Baystate. Completes initial site questionnaires, assesses, negotiates and prepares budgets in collaboration with sponsor, principal investigator and sponsored programs. Assesses work load and resource utilization issues. Initiate and coordinate monthly Research Review Committee to assess potential studies for scientific merit, resource utilization and budgetary feasibility. Prepares and submits IRB submissions. Assists in screening and enrollment activities according to specific protocols.

Management and supervision of a team of professional and paraprofessional employees. Focuses on practice standards, appropriate utilization of services and compliance with regulations and company policies. Responsible for assuring there is an appropriate match between patient’s needs and the skills of the clinician assigned. Utilize knowledge of business objectives and marketplace needs to identify staffing requirements and initiate the hiring of proficient caregivers.

Assist in recruiting, screening, and monitoring the status of subjects, for multi-specialty clinical drug trials conducted prior to FDA approval in an ambulatory care setting. Practiced and followed GCP guidelines and ICH regulations. Responsibilities include but are not limited to, monitoring of informed consent process, medical history review, source document completion, phlebotomy, infusions, EKG and lab data monitoring, physical assessment and monitoring for progression of AE’s. CRF review, generating, approving and tracking drug shipments and storage; reporting and writing narratives and follow-ups on serious AE’s. Interfacing with CRA’s from pharmaceutical companies and CRO’s.

Mshs May 2015, Clinical Research Administration

Bachelor Of Science, Health Care

Associate Degree, Nursing