Donna Sherer Rn, Ccrc Email and Phone Number

• Directs and manages all aspects of the clinical research programs, clinical trial operations and development including administrative/operations management and oversight of all clinical research projects ensuring timely completion of projects from study start up to study closure.• Ensuring site SOPs are consistent, reviewed and updated on a regular basis, that meets or exceeds regulatory and good clinical practice (GCP) standards, also ensuring SOPs and guidelines are observed by employees and Investigator's.• Creating, implementing and maintaining quality assurance plans per clinical trial. • Management of all research staff, including recruitment, interviewing, hiring, training,performance evaluations.• Marketing and recruitment of site abilities and qualifications to conduct sponsor clinical trials including but not limited to completing "Sponsor Site Qualification questionnaires , CDA and Protocol Feasibility forms".• Developing and assisting site and sponsor with budget preparation and contract negotiations toward acquiring a comfortable and workable budget and contract for both parties. • Assessing the financial feasibility of performing the study and the resources necessary to conduct the study, including people, physical space, materials, etc. • Initiates all new clinical trials and prepares regulatory start-up documents and IRB submission, as well as maintaining oversight of all essential documents.Problem-solving and communicating to the investigator and Sponsor. Professionally representing the site to all people/organizations in the best possible light.

• Received the designation of "Certified Clinical Research Coordinator" for having satisfied the standards of ethical and responsible clinical research, including substantial professional experience performing role-specific essential duties, demonstrating proficiency through a comprehensive examination, and committing to ongoing professional development in the practice of clinical research.

• Contacting, Screening and recruiting potential subjects for a study. • Scheduling subject visits and sponsor monitoring visits.• Preparing for each visit to ensure that all appropriate study procedures are done, also assisting the investigator with study subject visits. • Ensuring that all necessary data are gathered and recorded in the appropriate source documents (e.g., subject research charts) and on the sponsor data collection case report forms. • Reviewing case report form entries for completeness, correctness and logical sense, as well as any source documents for subject changes in baseline health that are adverse events to ensure none have been missed. • Entering subject data into an electronic data capture (EDC) system. • Working with sponsor monitors (CRAs) during monitoring visits. • Making corrections to case report forms.• Resolving data queries. • Ensuring that study documents are complete, current and filed correctly. • Ensuring that the investigational product accountability is done correctly overall and for each subject. • Managing laboratory procedures (drawing samples, processing, packaging and shipping).• Reordering study supplies as necessary. • Managing payments to study subjects.• Completing study closeout activities at the end of the study. • Maintaining regular communications with sponsors and/or CROs, IRBs and the institution.• Collaborating with other departments performing protocol procedures as necessary. • Problem-solving and communicating to the investigator. • Coordinating sponsor and/or regulatory study audits. • Helping to enlist new studies. • Professionally representing the site to all people/organizations in the best possible light. • Conducting all trial activities according to the appropriate federal and state regulations. • Ensuring the safety and well-being of all study subjects throughout the trial.

• Recruiting & Screening potential subjects for a study.

Charge Nurse - Endoscopy Center (Special Procedures)• Supervises and mentors staff during assigned shift. • Determines staffing level and assignments based on staff availability, • Developing staffing schedules including on- call coverage for procedures after hours and holidays. • Supervising and directing nursing care according to center policies, procedures, philosophy, andobjectives.• Shared responsibility for the fiscal activities of the clinical services.• Overseeing patient scheduling in clinical area.• Analyzing and evaluating nursing care to improve quality of care given.• Working closely with Nurse Manager, Center Director and other administrative and medical staff in coordinating patient care services.• Completing assigned projects in a timely manner• Provides direct patient care as needed. Floats between staff to assist with problem-solving. May take patient assignments to meet staffing needs. • Evaluates the effectiveness of patient care, including formal evaluation, and identifies any issues that affect desired patient outcomes. Responds to complaints about patient care and related services, and manages through established channels. • Performs role-specific duties as assigned, including entering orders, performing admissions or discharges, and coordinating transfers. Ensures staff has necessary equipment and supplies to provide safe, quality patient care.

EXPERIENCE HIGHLIGHTS: • Provided direct patient care in various settings over the years. • Maintained and recorded accurate and detailed flowsheets of patient's condition.• Reported any symptoms and changes in patient's condition.• Demonstrated critical thinking skills, specific judgment, and organization skills, prioritized tasks and adjusts priorities when necessary. • Managed and prioritized care of acutely ill medical patients receiving mechanical ventilation, both endotracheal and tracheal. • Administered medications via various routes and monitored patient for adverse effects. • Provided basic nursing care to patient's. • Educated families about patient's condition and provided support as needed. • BCLS• ACLS • Discharge Planning• At time facilitated flow of patient care among staff members. Creating staff assignments for current shift. Managing transfers and admissions. Maintains safety of all patients on unit. • Orients both new graduate and experienced nurses to the Surgical ICU. Reviews policies and procedures. Maintains safety of patients, while allowing independence by the orient. Educates orient on drips, ventilators, post-operative care, and general critical care nursing within the unit. Acts as resource for staff member once off orientation during employment at Princeton Baptist Medical Center (SICU Department).

• Contacting, Screening and recruiting potential subjects for a study. • Scheduling subject visits and sponsor monitoring visits.• Preparing for each visit to ensure that all appropriate study procedures are done, also assisting the investigator with study subject visits. • Ensuring that all necessary data are gathered and recorded in the appropriate source documents (e.g., subject research charts) and on the sponsor data collection case report forms. • Reviewing case report form entries for completeness, correctness and logical sense, as well as any source documents for subject changes in baseline health that are adverse events to ensure none have been missed. • Entering subject data into an electronic data capture (EDC) system. • Working with sponsor monitors (CRAs) during monitoring visits. • Making corrections to case report forms.• Resolving data queries. • Ensuring that study documents are complete, current and filed correctly. • Ensuring that the investigational product accountability is done correctly overall and for each subject. • Managing laboratory procedures (drawing samples, processing, packaging and shipping).• Reordering study supplies as necessary. • Completing study closeout activities at the end of the study. • Maintaining regular communications with sponsors and/or CROs, IRBs and the institution.• Collaborating with other departments performing protocol procedures as necessary. • Problem-solving and communicating to the investigator. • Professionally representing the site to all people/organizations in the best possible light. • Conducting all trial activities according to the appropriate federal and state regulations. • Ensuring the safety and well-being of all study subjects throughout the trial.

• Provided direct patient care to patient's with high acuities that are respiratory, cardiac and neurologically impaired. • Responsible for continuous monitoring and assessment of assigned patients.• Maintained and recorded accurate and detailed flowsheets of patient's condition.• Reported any symptoms and changes in patient's condition.• Demonstrated critical thinking skills, specific judgment, and organization skills, prioritized tasks and adjusts priorities when necessary. • Managed and prioritized care of acutely ill medical patients receiving mechanical ventilation, both endotracheal and tracheal. • Administered medications via various routes and monitored patient for adverse effects. • Provided basic nursing care to patient's. • Educated families about patient's condition and provided support as needed.