Job Details

PS Project Administrator

Job Summary Applicants must demonstrate the potential ability to perform essential job functions.

1. Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials.
2. Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards.
3. Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions.
4. Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight.
5. Provides assistance with personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans.
6. Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency.
7. Assist with study start up and oversee workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA, Feasibility, MDG scoring and navigation of review committees required for activation, etc.).
8. Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
9. Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB.
10. Manages the workflow by reviewing staff performance through period performance and salary reviews and revising the operating procedures as needed.
11. OTHER: Assume responsibility for additional assignments as directed by the Program Manager

Minimum Qualifications Requires Bachelor's degree in a related area or equivalency (2 years related work experience may be substituted for 1 year of education). Four to six years of progressively more responsible leadership experience. Background knowledge of hiring department's area of specialization. SOCRA or ACRP certified. Responsibilities Work Environment and Level of Frequency typically requiredNearly Continuously: Office environment.Physical Requirements and Level of Frequency that may be requiredNearly Continuously: Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.Seldom: Bending, reaching overhead. Minimum Qualifications Bachelor's degree in Business Administration, Accounting, or a related field, or equivalency (one year of education can be substituted for two years of related work experience); four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master's degree preferred. This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers, and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Preferences Successful Candidates Will Have:

• Three years of Oncology Clinical Research Coordinator Experience
• Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations
• Clinical Trial Management Software experience
• Ability to assess functional processes, workflow and develop improvements for efficiency and quality output.
• Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities; (i.e., complex trial designs, data standards, data reviews, etc.).
• Demonstrated ability to positively influence others in a team environment

Bachelor's degree in a related area of assignment or equivalency and 4 - 6 years of progressively more responsible oncology experience. Background knowledge of assigned department's area of specialization in order to analyze, plan, train and draw conclusions for recommendations to Clinical Trial Manager. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop team and to ensure the smooth operation of department. Completion of provided supervisory/management training within one year of employment may be required.