Jenny Schaefer Email & Phone Number

Hazelwood, Missouri, United States

Responsible for leadership and development of the department including such tasks as developing and revising departmental Standard Operating Procedures (SOPs) and developing training tools and service processes. Training staff in clinical research processes, clinical protocol review and clinical equipment functionality in order to gain necessary understanding of corresponding budgetary requirements. Serve as a member of the organization’s Pricing Committee with regard to budget negotiations. Review and approve budgets as well as execute budgets independently during times of high volume. Review and negotiate contract language. Manage the maintenance of the contracts database and regularly review and generate metric reports for distribution to executive staff.

Hazelwood, Missouri, United States

Responsible for working with the business to achieve the goal of process improvement and change management activities that enable and encourage the optimum performance of its staff and other resources within various business units. This was a newly developed role to define my services within the organization. My first assignment under this title was to provide these services to the Budgets & Contracts department. Prior to accepting the position of Director, Budgets & Contracts, I was successful in the development of new budgeting processes, revised Pricing Committee standards, and updated pricing for 2 of the 3 service departments (Pulmonary and Cardiac services) within the organization.

Hazelwood, Missouri, United States

Responsible for planning, directing and coordinating the operations of the department including work systems, procedures, and policies that enable and encourage the optimum performance of its staff and other resources within the business unit. Manage and increase the effectiveness and efficiency of Support Services through improvements to each function within the department. Manage staff and productivity of Pulmonary Data Management team. Supervise and mentor project managers/team leads. Develop and support better management reporting, information flow and business process.

Hazelwood, Missouri, United States

Responsible for ensuring Clinical Project Managers perform assigned duties at a level that meets or exceeds department quality standards. Serve as a supervisor, trainer and mentor for Clinical Project Managers. Perform quality reviews of study documentation including communications, protocol requirements, software customization requirements and validation requirements pertinent to protocol services. Review and approve developed protocol specific site training manuals, internal processing instructions, monthly billing, and study equipment status. Learn service offerings and organizational practices as well as personally execute organizational project management practices prior to assuming my position as Director, Clinical Operations.

Hazelwood, Missouri, United States

Responsible for executing needs assessments for a new clinical trial management system (CTMS) for the pending spin-off of Covidien’s branded drug operations to Mallinckrodt. Research and present system options, considering the input of stakeholders and operational needs, research and present product acquisition recommendations. Serve as the primary liaison for system vendors and the internal IT support team, ensuring the proper development, deployment and maintenance of systems. Ensure development of associated Standard Operating Procedures (SOPs). Create training materials and providing training for system use, and serve as the system administrator. Ensure project remains on time, within budget and in scope.

Hazelwood, Missouri, United States

Responsible for the recruitment, training and management of the Clinical Trial Associate (CTA) staff. Create, maintain, and assume accountability for a culture of high customer service; facilitate communication and alignment within and across functional lines; and prioritize and assign CTA resources to provide optimal service to Clinical Operations. Responsible for managing the Clinical Trial Management System (CTMS). Interface with cross functional departments and CTMS product vendor regarding training, issues and user questions for the electronic CTMS, serve as system administrator and committee member for all upgrades/enhancements to the system, create training materials and execute end-user training. Responsible for the management, oversight and audit ready status of Trial Master Files (TMFs) associated with clinical operations. Perform and execute QA review and inspection of TMF documentation maintained by outsourced vendors.

Hazelwood, Missouri, United States

Responsible for the development of a new TMF template and subsequent coordination and oversight of the maintenance of electronic and paper-based clinical trial files in accordance with SOPs and FDA, ICH and GCP guidelines and regulations. Perform project quality assurance including auditing internal TMFs, regulatory files at clinical sites and outsourced CRO-managed TMFs. Enter data into the CTMS and act as the CTMS Administrator with staff training and system troubleshooting responsibilities. Analyze work processes for efficiency, suggesting and making improvements and developing written procedures for project work processes; assuring workflow continuity.

Hazelwood, Missouri, United States

Responsible for introducing and formally establishing a Clinical Trial Associate (CTA) line of service within the organization. Develop Standard Operating Procedures and associated work processes. Serve as the sole CTA for ongoing clinical trials. Maintain essential documents for Trial Master Files (TMFs). Participate in the development of a Clinical Trial Management System (CTMS).

St Louis, Missouri, United States

Responsible for creating, maintaining and routinely auditing TMFs, ensuring FDA audit-readiness. Coordinate and execute site start-up activities including processing of site regulatory documents and clinical supply and drug distribution. Act as designated sight contact for regulatory and supply issues through the duration of clinical trials. Coordinate and execute site close-out regulatory processes, equipment return and drug return. Responsible for tracking and managing study specific monitoring plans. Perform initial review on monitoring reports for the purpose of ensuring completeness, appropriate time-point content before forwarding to the Program Director. Facilitate effective communication between investigative sites and the project team through written, oral and/or electronic contacts. Assist the clinical project team in identifying, documenting and evaluating project risks throughout the project life cycle and implementing corrective action as appropriate. Develop, review, enhance and maintain administrative systems and procedures for the conduct of clinical research studies including electronic databases and operational files.

St Louis, Missouri, United States

Responsible for managing and providing leadership to the clinical trial research coordinator staff while ensuring the facilitation of clinical trials and adherence to GCP/ICH regulations and protocol-specific guidelines for Phase I-III oncology studies. Specifically responsible for Surgical, Radiation and Phase I clinical oncology research operations. Hire, train and provide performance evaluations, assess workloads and allocate/schedule resources of the clinical trial coordinator staff. Randomly audit and regularly monitor Case Report Forms (CRFs) and study documentation for multiple studies to ensure proper and compliant reporting. Negotiate contracts, create and negotiate budgets, establish and manage internal accounts for trial related treatment. Ensure study timelines, costs and maintenance of quality metrics. Initiate program improvement initiatives and participate in the development of policies and procedures.

St Louis, Missouri, United States

Responsible for overseeing daily operations of research coordinators, coordinating trial activities within the breast cancer clinical group, providing training, making staff assignments, monitoring delinquency lists and pathology submissions. Monitor data collection and CRF entry for accuracy and compliance. Develop systems to track patient visits and ensure team members are available to complete protocol requirements. Serve as subject matter expert for clinical work group; assist with workload analysis by monitoring day to day workloads. Facilitate communication with Principal Investigators to ensure study objectives are met, schedule and facilitate site visits by external monitors and auditors, ensure data is collected and recorded according to standards of GCP/ICH guidelines and communicate with auxiliary sites. Source-verify CRFs and study documents for a pre-existing multi-center trial to provide input to the PI for the purposes of publication development. Assist in protocol and CRF development for Investigator Initiated studies.

St Louis, Missouri, United States

Responsible for the development and management of the Spinal Cord Injury Clinical Research Program. Ensure facilitation and adherence to GCP/ICH regulations and protocol-specific guidelines for Phase I-III studies. Develop and negotiate budgets, assist in contract negotiations, estimate and assign resources and manage program finances. Coordinate all clinical trial program activities from start-up to study close. Communicate regularly with physicians, sponsors and other study related personnel to review study status/activity to ensure study timelines, costs and quality metrics are met. Train and supervise research assistants and study coordinators. Complete, submit and maintain all required regulatory documentation including development of study-specific Informed Consent Forms. Recruit, screen and enroll study participants. Execute the Informed Consent process and act as liaison between patient and investigators to ensure continued patient participation. Complete all source and CRF documentation (hard copy and electronic) required by the study, including documentation and submission of SAEs and protocol deviations. Perform clinical procedures with subjects including obtaining vitals, performing ECGs and bone density scans, collection and shipping of specimens (blood, urine and tissue) and dispensing of study medications. Travel to sites participating in Investigator Initiated multi-center studies and to industry sponsored Investigator Meetings. Collaborate with investigators to provide input for protocol development and literature publications.

• Provide administrative support to Dr. John McDonald, Director of the Spinal Cord Injury Program• Perform as liaison and primary contact for the Spinal Cord Injury Program• Initiate and conduct internal and external advertising initiatives• Assist grant coordinator with grant submissions • Generate and maintain all documentation for the establishment and operation of the newly developed program, including but not limited to: expense reports; travel arrangements; reimbursements; correspondence; medical record notes/charts; manuscript submissions; and supply orders• Answer phones; greet visitors; arrange meetings; coordinate conferences; photocopying; faxing; scanning and other duties as needed• Provide supervision support to Dr. McDonald’s research lab and personnel

• Provide administrative support to the Stroke Management and Rehabilitation Team under the direction of Dr. Chung Hsu, Head of Cerebral Vascular Disease• Ensure a smooth operating outpatient clinical practice• Assist with clinical trial data management (Phase II-III stroke trials)• Handle patient dictation; type correspondence and reports; schedule patient appointments; obtain patient referral/pre-certifications and medical records; schedule labs and diagnostic testing; and handle/organize patient admissions• Maintain/update patient charts through regular collection of procedure reports and physician notes• Answer phones; greet visitors; arrange meetings; coordinate conferences; organize mass mailings; filing; copying; faxing; scanning and ordering of office supplies• Assist grant coordinator with grant submissions

• Provide administrative support to multiple physicians for both research lab and clinical practices• Transcribe patient dictation, generate correspondence, reports and journal reviews• Schedule patient appointments and lab/diagnostic test procedures• Maintain/update patient charts through regular collection of procedure reports and physician notes• Process purchasing of lab equipment, animals and supplies• Answer phones; greet visitors; arrange meetings; coordinate conferences; organize mass mailings; filing; copying; faxing and scanning.• Assist grant coordinator with grant submissions