PRIMARY FUNCTION:

The Study Processing Manager is responsible for managing the processing team in the coordination, management and execution of assigned clinical trials.

ESSENTIAL FUNCTIONS:

• Implements and monitors clinical trials to ensure study obligations are being met and are compliant with applicable local regulatory requirements and ICHGCP guidelines
• Manage procedures and Study Processing Specialists performance to ensure goals are met for our clients
• Periodically review policy and procedure documentation to ensure accuracy
• Create team training and maintain training records
• Monitor and track visit progression through AEBC processing steps to ensure turnaround times and prioritization requirements are met
• Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.

OTHER FUNCTIONS AND COMPETENCIES:

• Ensure all study internal manuals and forms, and reader materials are accurate and up to date throughout the study. This includes a periodic review of materials against the protocol to ensure no updates are required,
• Create training materials and conduct internal trainings to ensure all study staff are up to date on required procedures.
• Support project teams in performing quality control checks to ensure accuracy of materials and deliverables
• Communicate with AEBC Leadership regarding operational deliverables on assigned studies
• Participate in internal and external audits
• Maintains client (internal and external) satisfaction by ensuring timely processing of all study related data

• Establishing a rapport with site personnel, clients and others in a position to help meet the clientrsquo;s needs
• Responding to inquiries in a professional, courteous and timely manner
• Other duties as assigned

POSITIONS, SUPERVISED OR DIRECTED (TITLES AND APPROXIMATE NUMBERS):

Study Processing Specialists (7), Study QA Specialist (1)

Numerous external client contacts.

All staff of Annesley Eye Brain Center

SOCRA or Project Management Certificate preferred

10 years of experience in clinical research or related field

ADDITIONAL INFORMATION:

• Strong Excel and Word skills, intermediate level
• Excellent verbal and written communications skills.
• Strong organizational, interpersonal and team skills
• Able to prioritize study load and associated tasks.
• Strong attention to detail and ability to take ownership of complex issues, ensuring resolution.
• Knowledge of clinical research, GCP, GCDMP and related regulatory requirements.

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Jefferson Health delivers state of the art healthcare services to patients throughout the Delaware Valley and southern New Jersey. Jefferson (Philadelphia University + Thomas Jefferson University) provides more than 8,400 full and part-time students from nearly 40 states and 40 countries with 21st century professional education. Combined, we have over 30,000 employees.

Jefferson Health, with 14 hospitals (seven are Magnet designated by the ANCC for nursing excellence) and 40+ outpatient and urgent care locations, offers a broad range of primary and complex, highly specialized care that touches the lives of more than four million patients annually. U.S. News amp; World Report has ranked Thomas Jefferson University Hospital among the nationrsquo;s best in eight specialties. Jefferson Health also includes the NCI designated Sidney Kimmel Cancer Center; it is one of only 70 such centers in the nation.

Thomas Jefferson University has ten colleges and three schools that offer more than 160 undergraduate and graduate programs. Our University is dedicated to inter-professional and transdisciplinary approaches to learning that offer a vibrant and expandable platform for professional education. Through this unique model, we are preparing our students for current and yet to be imagined careers.

As an employer, Jeffersonmaintains a commitment to provide equal access to employment. Jefferson values diversity and encourages applications from women, members of minority groups, LGBTQ individuals, disabled individuals, and veterans.

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