How This Role Makes a DifferenceThe
Site Manager is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials.
How You'll Make An Impact- Management of Studies and Site Workload:
- Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
- Coordinate Investigator and Sub-Investigator coverage
- Work with Region Manager to identify outside vendors needed for studies
- Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
- Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
- Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
- Update Region Manager on all pending and active study details
- Oversee all site staff's work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
- Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
- Attend all study audits and play an active role in their management and execution of follow up items
- Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
- Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
- Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
- Personnel:
- Review and approve PTO requests, ensuring there is adequate coverage at the site
- Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
- Participate in the interview process for site staff
- Ensure site staff complete all required training
- Encourage a positive team-oriented environment
- Work with Region Manager to ensure high staff morale and low turnover rates
- Report all personnel issues to Region Manager
- Conduct weekly one on ones with staff and maintain appropriate documentation
- Lead by example and display a high level of integrity and professionalism.
- Financial:
- Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
- Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
- Work with Region Manager to identify and communicate staff needs
- Ensure there are adequate supplies and equipment on site
- Site Maintenance:
- Keep Region Manager apprised of any site maintenance issues
- Coordinate building and equipment maintenance
- Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives
- Ensure staff are following guidelines and SOP's as pertain to the sites
- Ensure that site have the equipment necessary to safely perform job responsibilities
- Work with the Region Manager to review and address injury reports if necessary
- Ensure the lab follows IATA guidelines and applicable staff are properly certified
- Collaborate and communicate with other departments regarding inter-site issues
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
The Expertise Required- Strong organizational and planning skills to maintain a busy and diverse work schedule
- Proactive approach with the ability to work autonomously
- Excellent problem-solving skills
- The ability to multi-task and work well within a high-paced pressurized environment
- The ability to use your initiative to deliver a great customer experience
- Excellent communication skills paired with the ability to develop and nurture relationships
- Intermediate/Advanced IT skills including experience of using Word, Excel, Outlook and PowerPoint
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Ability to communicate and work effectively with a diverse team of professionals
- Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
- Critical thinker and problem solver
- Excellent interpersonal skills, detail-oriented and meticulous
- Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
- High level of self-motivation and energy
- Excellent professional writing and communication skills
- Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals
- Ability to work evenings and weekends as needed
- Must have access to reliable transportation
Certifications/Licenses, Education, and Experience- Bachelor's Degree or equivalent professional experience
- Research Professional Certification
- A minimum of 5 years of clinical research experience
- A minimum of 3 years prior Clinical Research Coordinator experience
- Previous Research Site Management experience preferred
- Spanish fluency preferred
How We Work Together- Location: This is an on-site position with regional commute requirements.
- Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $80,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
