Retinal Research Institute, one of the nation's largest retina and vitreous-specific research organizations, is seeking a Research Department Manager. Affiliated with Retinal Consultants of Arizona, Retinal Research Institute is involved in multi-center Phase I, II III and IV research trials sponsored by pharmaceutical companies and the National Eye Institute, as well as Investigator-Sponsored Trials (ISTs). The research manager will oversee the functioning of the department to ensure that concise clinical data is provided to Sponsors in a timely manner and according to study protocol. The research manager will directly manage all department staff and will be responsible for the creation and implementation of department policies and procedures.
About Retinal Consultants of Arizona: Retinal Consultants of Arizona (RCA) was founded in 1980 in central Phoenix. Today the practice has 11 ophthalmologists and sees patients at 32 locations throughout the state of Arizona. RCA is Arizona's largest and most experienced ophthalmology practice focused specifically on the diagnosis and management of the retina and vitreous.
The practice has partnered with BSM Consulting (www.bsmconsulting.com) to conduct the application process.
REPORTS TO: Chief of Operations and Managing Partner
JOB SUMMARY: The research department manager will oversee the functioning of the department to ensure that concise clinical data is provided to sponsors in a timely manner and according to study protocol. The research manager will also directly manage all department staff and will be responsible for the creation and implementation of department policies and procedures.
EXAMPLE OF DUTIES AND RESPONSIBILITIES: (This list may not include all of the duties assigned)
Be familiar with and stay up-to-date with changes to the Code of Federal Regulations Titles 21 and 45, and GCP and ICH Guidelines
Execute FDA and sponsor initiated audit requests in a timely manner
Review all new protocols / protocol synopses for feasibility
Maintains current list of all enrolling studies with inclusion/exclusion criteria, offices offered, length of trial, and transportation details.
Keeps current copies of all informed consents and protocol updates.
Working closely with coordinators to get patients in for screening and treatments if patients do not qualify for study participation.
Facilitate the execution of Confidentiality and Disclosure Agreements in a timely manner
Complete Feasibility Assessment questionnaires in a timely manner
Schedule and facilitate all Sponsor site visits
Maintain communication via phone and e-mail with study feasibility team to ensure involvement in the research study
Evaluate all Clinical Trial Agreements and budgets with practice controller
Manage contract and budget approval process with Sponsor and practice signatories and controller
Assign new study protocols to research coordinators
Manage day-to-day research operations, including scheduling of coordinator meetings as needed
Implement procedural and policy (SOP) changes to improve operational efficiency in the Research Department
Participate in the employee review process
Participates in coaching, counseling, monitoring and disciplining of research and support staff
Train new research staff as needed
Conduct literary reviews and statistical analyses as requested
Provide physicians with photographs, tables and graphs for publication and presentation, as requested
Update Investigator CVs as required
Ensure that current CVs are available for all research staff
Authorize submissions to journals for publication
Attend all monthly research meetings and manager meetings, and be available to meet with physicians, managers and clinic staff as needed
Back-up as a Clinical Research Coordinator
The practice has partnered with BSM Consulting (www.bsmconsulting.com) to conduct the application process. No calls or emails please.
REQUIREMENTS: The position requires a valid driver's license, proof of auto insurance and insurability with the corporate liability carrier. Position requires that you can be contacted by cell phone in the event of staffing changes. Position requires that you have adequate transportation in the event of a change in designated work location and/or if travel is required.
EDUCATION AND EXPERIENCE:
Associate's or Bachelor's degree in a science- or business-related field
At least five years of work experience in the clinical research field. Ophthalmology experience preferred