Manager Clinical Research

Summary of Responsibilities: The person in this role is responsible for having thorough knowledge and complete functionality in all aspects of the Clinical Research department - this includes, but is not limited to, all essential functions listed on current Clinical Research Coordinator job description. In addition, this role will provide supervisory oversight, perform managerial administrative tasks, and assist with or provide training and development to other team members in Clinical Research department.  The person in this role must support all initiatives of the Director of Patient Care Operations and management staff, both verbally and behaviorally. 

• Assists as directed with administrative and financial activities associated with the conduct of clinical trials.
• Arrange for study set-up (space, staffing, phones, computers, printers, copiers, binders, storage and other trial specific equipment).
• Acts as a liaison between site, sponsor and all related agencies.
• Handles all institutional review board documentation and correspondence; including initial submissions, protocol amendments and renewals, informed consent documents and modifications, unanticipated event reporting and serious adverse event reporting.
• Ensures compliance by coordinating all aspects of patient care to research protocols while following GCP guidelines.
• Manages research project databases, develops flow sheets and other study related documents, completes source documents and caser report forms.
• Reviews as directed confidentiality agreements, sponsor budget templates and clinical trial agreements.
• Prepares regulatory submissions, technical progress reports and sub-contracting reports.
• Assists in completing continuation applications and study extensions.
• Develops recruitment strategies and conducts screenings for study subjects, including interviews and questionnaires.
• Reviews as directed protocols to determine financial and resource feasibility.
• Networks with study sponsors for new studies extension. 
• Maintain and upkeep of all site standard and regulatory operating procedures for research
• Monitors study procedures, scheduling of procedures and charges and coordinates other outside services as needed.
• Interfaces with research participants, determines eligibility and consents study subjects according to protocol.
• Completes and analyzes ophthalmic related diagnostic tests and requirements.
• Provide interpretation of diagnostic test results to study participants and related personnel. Keep drug accountability, randomization and subject logs.
• Coordinates with Patient Financial Services to obtain CPT codes and reviews billing for payments.
• Coordinates with Patient Financial Services to ensure purchase orders are processed, deliveries tracked; invoices approved, and transactions tracked within appropriate systems.
• Reviews contracts and indemnification agreements from funding agencies, in coordination with or as directed by Patient Financial Services.
• Supervises collection of study specimens, their processing, storage and shipping.
• Works with investigators to develop and write protocols for clinical trials and prepare supporting documents for grand and IRB approval.
• Maintains study equipment logs and calibration.
• Conducts site monitor visits and site regulatory audits.
• Acts as Ophthalmic Technician when directed, based upon needs of clinic.
• Adheres to all policies and procedures as outlined in the Employee Handbook.
• Responsible for insuring time and attendance procedures are followed in department and insuring PTO requests are responded to in timely manner and updated in timekeeping system as well as insuring time cards of team are correct and submitted by deadlines
• Assist in and/or are responsible for mentoring and training assigned team members whose performance is below clinic standards and expectations.
• Responsible for effectively working with other teams, both administrative and clinical to insure clinical research studies and projects run smoothly. 
• Contribute to and/or perform audits and evaluations, coordinating with Director and/or Managers in Patient Care Operations area as applicable
• Responsible for supporting training, including but not limited to, new hire training, internal transition