Clinical Research Manager

Come and join our team! We are a local growing private medical practice specializing in the diagnosis and treatment of patients with diseases of the retina and vitreous. We are looking for individuals who would like to establish a career in healthcare working with nationally recognized physicians. We provide on the job training giving you the ability to grow and advance your skills along with gaining innovative knowledge. Established in 1977, we have locations all over Northern California including Sacramento, Grass Valley, Roseville, Stockton, Modesto, Merced, Fairfield, Elk Grove, Folsom, Yuba City and Chico. Our physicians are nationally known, and we continue to be on the leading edge of retina care by utilizing the latest equipment and both participating in and designing new clinical trials to advance the state of care for retinal diseases. Join 250 other team members working for our nationally recognized retina specialty practice in a fast paced, high volume medical office.

The Research Manager is primarily responsible for management of multi-center studies/clinical trials and strong interpersonal, communication, and project management skills, as well as be comfortable interacting with individuals at all levels of clinical research – from research assistants and Principal Investigators to patients enrolled in the study. The individual should be able to manage a large research team, provide them with guidance and jump in to help complete tasks when needed. This position ensures adherence to all applicable regulations, Good Clinical Practices, and industry standards governing research involving human subjects; and ensures that clinical studies are performed with the upmost integrity and quality.

As our Clinical Research Manager, you will lead in the planning, development and implementation of clinical research trials involving the study of agents to treat diseases of the retina, macula and vitreous.

Responsibilities:

• Staff management and proactive assessment of staffing needs to include hiring, training, and coaching/mentoring staff
• Provide mentorship and guidance to team members and cross-functional staff on study processes and study requirements
• Manage site workflow to ensure that patients/subjects, staff, and sponsors have the best customer service experience
• Oversight of study management including timely review of monitor reports and associated study deliverables
• Oversight of site study audits and inspections as needed
• Identify, assess, and work with the QA team to resolve site performance and quality/compliance issues
• Coordinate and manage various tasks in collaboration with the QA team & Regulatory Manager to achieve site readiness for timely first patient first visit
• Obtain and maintain in-depth understanding of the study protocols and related procedures in order to contribute to the study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as needed/required
• Ensure site meets monthly screening, randomization, and completion/retention goals by assessing scheduling, troubleshooting, and maximizing staff availability
• Follow a quality process as outlined in the Site's/RCA’s SOP's to ensure the site collects and enters high quality data and to reduce preventable deviations
• Ensure the site has high morale and works well as a team and meets our cultural goals and expectations
• Step into role as coordinator/research assistant as needed to assist the team
• Coordinate with general clinic Manager so assure effective integration of clinical research and regular clinical patient care

• Strong experience in clinical research and staff management
• Able to hire, train and develop staff
• High degree of organization and planning: Plan, organizes, schedules in an efficient, productive manner, focusing on key priorities
• A strong work ethic: Willing to step in to assist the team when needed
• A team player who can receive and provide constructive feedback
• The ability to motivate and inspire a team to function at its highest capacity
• Excellent verbal and communication skills
• Excellent organization skills and attention to details
• Strong supervisory and leadership skills

Minimum Requirements:

• Bachelor’s Degree Required
  
• Ophthalmic Experience Preferred
  
• 5 years of clinical research operations management-level experience preferred
  
• Excellent knowledge of ICH GCP guidelines; CCRP certification preferred
  
• Strong experience in clinical research is preferred
  
• Experience in people management and management best practices is required

Physical Requirements:

• Must be able to stand for long periods of time
• Must be able to write
• Must be able to hold arms at shoulder height
• Must be able to communicate via telephone
• Must have manual dexterity to work with ophthalmic equipment

Full-time immediate employee benefits:
Paid Time Off (PTO) 13 days per year, as accrued.
7 Paid Holidays per year.
Scrub Allowance
Ability to participate in company 401k plan offered through Fidelity.

On the first of the month following 30 days of employment benefits:
Medical insurance – employer pays 95% of premium of base HMO plan for employee (dependent coverage available for purchase).
Group dental, vision, life, and accident plans available for purchase.
Flexible Spending Account participation available.
Allows pre-tax deferrals of amounts for medical, dental or vision premiums
Allows pre-tax deferrals for dependent care expenses, subject to limitations

After 90 days of employment – Paid Sick Leave of 5 days per year.

After one year of service – 401K Plan Safe Harbor contribution (3% of annual earnings) received after plan year ends.