Manager, Clinical Research

Description

Who We Are

At Panorama Eyecare company, we are not just a team; we are a community of dedicated professionals united in our quest to provide the best eyecare anywhere. Our unflinching commitment to excellence and our core values are what make us an Employer of Choice. Join us in shaping the future of eyecare as we thrive together! 

The Position:

  Key ResponsibilitiesStaff Supervision & Training

• Supervise, support, and evaluate clinical research staff.
• Ensure staff are appropriately trained and qualified to perform delegated study responsibilities.
• Coordinate training on new and updated study equipment, technologies, procedures, and modalities.
• Ensure staff are trained on all required modalities for new and existing studies.
• Maintain staff competency related to image certification, phlebotomy, and other study-specific procedures.
• Ensure completion and documentation of ALCOA and applicable GCP training.
• Identify training gaps and provide or coordinate retraining as needed.
• Participate in staff recruitment, onboarding, payroll, recognition, performance management, and disciplinary processes.

Regulatory & Compliance Management

• Maintain accurate and organized regulatory documentation for all clinical trials.
• Ensure CVs, GCP certificates, professional licenses, liability insurance, and other credentials remain current.
• Coordinate with licensing and other appropriate entities to obtain updated physician licenses and annual liability insurance documentation.
• Maintain current, inactive, and expired staff credentialing files and binders.
• Develop and maintain study-specific Standard Operating Procedures (SOPs) and Notes to File (NTFs), as applicable.
• Coordinate study start-up requirements, including preparation and submission of required ICF documentation to the IRB.
• Ensure timely submission and documentation of Serious Adverse Event (SAE) reports to the IRB and applicable safety teams.
• Ensure study close-out regulatory files contain appropriate documentation for all study personnel, including GCP, CVs, licenses, and insurance.
• Ensure study documents are appropriately archived and transferred to long-term storage according to applicable requirements.

Equipment & Environmental Monitoring

• Ensure study equipment receives required annual quality control and maintenance in accordance with applicable ASC and study requirements.
• Maintain monthly calibration records and equipment logs.
• Monitor expiration dates for thermometers and other equipment to prevent loss or damage to investigational product.
• Monitor and document temperature excursions and ensure appropriate corrective actions are taken.
• Ensure equipment and environmental records remain complete, accurate, and inspection-ready.

Quality Control & Study Oversight

• Conduct weekly QC reviews of charts and study documentation.
• Prepare and communicate QC reports to identify and address transcription, scribing, documentation, and other errors.
• Assign patient charts and study responsibilities to staff approximately two weeks in advance to support timely preparation.
• Monitor ModMed and CRIO to ensure appointment accuracy and appropriate study scheduling.
• Conduct quarterly QC reviews of appointments and visit windows.
• Track sponsor visit findings, corrective actions, and follow-up items to ensure timely resolution and closure.
• Monitor trends in protocol deviations and implement retraining or corrective actions when necessary.
• Promote a culture of continuous quality improvement and protocol compliance.

Patient Recruitment & Study Enrollment

• Support research staff with recruitment reports and enrollment activities.
• Recruit and pre-screen potential participants through telephone outreach and in-clinic engagement.
• Facilitate same-day screening opportunities when appropriate.
• Support recruitment strategies designed to meet or exceed study enrollment goals.
• Develop and maintain relationships with current and prospective sponsors.
• Proactively identify and pursue opportunities to bring new studies to the site.
• Maintain knowledge of current and upcoming clinical research opportunities and therapeutic areas.
• Promote the site as a high-quality, reliable, and high-enrolling research partner to sponsors and CROs.

Source Documentation

• Develop and maintain source documentation for all clinical trials using CRIO or approved paper-based systems.
• Ensure source documents are accurate, complete, timely, and consistent with study protocols.
• Ensure source documentation and paper logs align with ECRF requirements and study-specific guidelines.
• Ensure appropriate coding and configuration is completed within CRIO when required.

Financial & Invoice Management

• Track physician-to-physician/sub-investigator reimbursements and payments.
• Track monthly technology incentives and submit appropriate information to payroll.
• Manage study invoicing and identify billable activities that are not automatically captured by the system.
• Review each participant visit to ensure all applicable invoiceable items are captured and submitted.
• Track and submit receipts, mileage, and patient reimbursement documentation, including appropriate redaction.
• Follow up on monthly, quarterly, and outstanding invoice payments.
• Ensure applicable record-retention and study close-out fees are billed.
• Reconcile monthly research payments with Finance using appropriate tracking spreadsheets.
• Prepare quarterly financial reports detailing physician-to-physician payments, patient stipends, historical payments, and technology reimbursements.
• Coordinate quarterly research finance meetings with research physicians.
• Collaborate with the billing department monthly to ensure research participants are not incorrectly billed for study-related services.
• Monitor EYP injections and other research-related charges posted in ModMed.
• Provide invoice payment and check information once charges are paid.
• Maintain appropriate chart alerts for billing and clinical staff.
• Notify billing of new studies, participant enrollment, and study start/stop dates.

Contracts, Budgets & Sponsor Negotiations

• Negotiate study contracts and budgets with sponsors in accordance with established site pricing and financial requirements.
• Evaluate current market pricing and benchmark site rates as appropriate.
• Ensure appropriate overhead percentages are incorporated into study budgets.
• Prepare letters of proposal and other budget-related communications as needed.
• Evaluate study financial feasibility and ensure adequate profitability based on anticipated enrollment and workload.
• Monitor enrollment performance against financial and contractual projections.
• Review investigator agreements with investigators to ensure terms are appropriate, feasible, and aligned with study responsibilities.
• Coordinate contract updates and addenda as needed.
• Maintain awareness of document-retention and long-term storage requirements.

Cross-Departmental Collaboration

• Collaborate with surgical and ASC teams on surgical clinical trials.
• Train and educate OR and ASC staff regarding study-specific requirements and procedures.
• Coordinate with ASC leadership to manage OR scheduling and make adjustments based on study case requirements.
• Ensure sponsor visitors are appropriately credentialed for ASC access and provide required documentation to ASC administration.
• Maintain ongoing communication with clinic staff regarding current and upcoming research studies.
• Develop and distribute study communications, newsletters, and educational materials to clinic staff.
• Coordinate Lunch and Learn sessions to educate clinical and administrative teams about research opportunities and study requirements.
• Collaborate with Principal Investigators (PIs) to identify appropriate Sub-Investigators.
• Coordinate discussions with Sub-Investigators regarding participation, training, delegation, responsibilities, and study expectations.

Sponsor & Business Development Activities

• Maintain strong professional relationships with sponsors, CROs, investigators, and research partners.
• Represent the research site professionally at conferences and industry events.
• Coordinate and host off-site recruitment dinners and similar sponsor-supported events.
• Ensure appropriate sponsor payment and financial arrangements are established for recruitment events.
• Support the site's reputation as a quality-focused, reliable, and high-performing clinical research partner.The Clinical Research Site Manager is responsible for the overall operational, regulatory, financial, quality, recruitment, and administrative management of clinical research studies. This role supervises and trains research staff, ensures compliance with study protocols and regulatory requirements, oversees study start-up and close-out activities, manages equipment and quality control processes, supports patient recruitment and enrollment, and serves as a key liaison between investigators, sponsors, vendors, clinical departments, and organizational leadership.

 Additional Management Responsibilities

• Participate in overall research department planning and operations.
• Manage staffing needs, recruitment, onboarding, training, scheduling, and performance management.
• Support payroll and staff recognition activities.
• Address performance concerns and disciplinary matters in accordance with organizational policies.
• Coordinate departmental meetings and educational activities.
• Ensure research operations remain organized, compliant, financially sustainable, and aligned with organizational and investigator goals.

Requirements

Who You Are

Performance/Skills Requirements:

• Good verbal and written communication skills, high attention to detail and accuracy.
• Commitment to accurate and ethical trial conduct.
• Ability to learn and follow numerous study protocols simultaneously. 

Education/Certifications/Experience:

• High School Diploma Required.
• COA/COT and/or CCRC required. All certifications must be maintained.
• Two or more years of leadership/management experience in a research setting preferred.

Physical Demands:

• Ability to be on feet and sit for long periods of time.
• Ability to lift up to 25 pounds without pain or restriction.
• Ability to raise hands and arms to shoulder level without restriction, pain, or discomfort.    
• Ability to perform extended use of office and diagnostic equipment without pain or discomfort.

Additional Job Details

• Works at our clinic location at 3151 Precision Dr. Fort Collins, CO 80528.
• This is a Full-Time Position.
• Compensation for this role will be an annual salary of $70,000-78,000 depending on experience/certification. 

Our Growth Opportunities

At Panorama Eyecare, we care about our employee’s ability to grow within the company. Therefore, we have created career growth plans that allow employees the ability to work toward their professional growth. We encourage all employees to apply for internal openings they may be qualified for, and we welcome the opportunity to interview and coach employees on how to grow. 

Our Employee Perks

• PTO Accruals Start at 3 Weeks 
• Comprehensive Medical and Dental Insurance 
• Company Paid Optical Allowance
• Company Paid Routine Eye Care
• Short Term and Long-Term Disability Insurances
• Educational Allowance
• Generous Paid Holiday Program
• 401K With Company Match

Join Our Team!

Embark on a rewarding journey with Panorama Eyecare and become part of a team that embodies the values of Partnership, Engagement, Excellence, and Stewardship. As an Eyecare Professional, you will not only provide exceptional patient care, but also shape the future of our practices. Together, we are transforming the eyecare landscape. Apply now and let your passion for excellence and patient well-being shine! 

EEOC

Panorama Eyecare is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any characteristic protected by law.