Clinical Project Managers III

About the role

Coordinate all aspects of clinical studies from initiation through delivery. Build and maintain relationships with sponsors, investigators, and research staff. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Maintain required records and ensure compliance with protocols, regulatory regulations, and overall clinical objectives. Record adverse event and side effect data and confer with investigators regarding reporting of events to oversight agencies. Utilize project management methodologies, lead cross-functional teams, resolve issues within the clinical study, and ensure that all targets, timelines, budgets, and requirements are met.

Responsibilities

• 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.
• Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards.
• Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions.
• Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight.
• Provides assistance with personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans.
• 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.
• 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.).
• Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs).
• Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB.
• Manages the workflow by reviewing staff performance through period performance and salary reviews and revising the operating procedures as needed.
• Assume responsibility for additional assignments as directed by the Program Manager.

Minimum Qualifications

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Clinical Project Manager, III: Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience.

Preferences

• 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
• Four to six years of progressively more responsible leadership experience
• Background knowledge of hiring department's area of specialization
• SOCRA or ACRP certified
• 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

Pay

$60,000 to $78,000

Schedule

Full Time