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Clinical Research Manager at Colorado Retina Associates

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Denver, Colorado





Job Description:

Colorado Retina Associates is looking for a Clinical Research Manager!

Colorado Retina is a thirteen physician, sub-specialty eye care practice providing medical and surgical care of vitreoretinal eye disease. We provide comprehensive treatment for age-related macular degeneration (AMD), diabetic retinopathy, retinal vascular disease, retinal detachments, ocular tumors, uveitis/inflammatory eye disease, inherited retinal degenerations and numerous other vitreoretinal conditions.
We are proud to be the largest retina practice in the Rocky Mountain region with the ability to collaborate as a team for highly complex cases. We provide five service locations in the Denver Metro area: East Denver (Central Park), Englewood, Lakewood, Lafayette, Parker, and Summit County.

Colorado Retina Associates is complying with the Covid-19 Vaccine Mandate. Colorado Retina requires employees to be vaccinated as a condition of employment, subject to accommodation. All candidates, upon hire, will be required to provide proof of vaccination.

Position Summary:
The Clinical Research Manager will have experience in management of multi-center studies/clinical trials, strong interpersonal communication, and project management skills, as well as be comfortable interacting with individuals at all levels of clinical research. This will include 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.

Role and 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


Financial Administrative:

Maintain a tracking system of study related costs
Generates monthly reports for each clinical trial, monthly financial reports for clinical research, and monthly reports for distribution of patient visits/meetings/enrolled patients for each physician.
Works with finance/accounting department as needed for study costs and department budget


Education and Experience:

Bachelor's Degree or equivalent in years and experience required
Ophthalmic Experience Preferred but not necessary.
5+ years of clinical research operations management-level experience preferred
Excellent knowledge of ICH GCP guidelines
Strong experience in clinical research is preferred
Experience in people management and management best practices


Preferred Skills/Experience:

Strong experience in clinical research and staff management
Able to 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


Certificates & Licenses:
CCRP certification preferred

Our Benefits Include:

Competitive salary
Safe harbor/profit sharing plan
Full medical, dental, and vision insurance
Pet insurance
Legal, life, accident, disability, and hospitalization insurance





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