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Job description
Care Access is working to make the future of health better for all.With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need,and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
The 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:
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
Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
Partner with the Region Manager to 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
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:
Through partnership with the Region Manager 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
Work with Region Manager to develop a positive team environment, striving for high staff morale
Work in conjunction with Region Manager to manage personnel challenges
Conduct weekly one on ones with staff and ensure staff complete all required training
Work with Region Manager to identify staffing needs for the site
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
Site Maintenance:
Keep Region Manager apprised of any site maintenance issues Coordinate building and equipment maintenance
Ensure staff are following guidelines and SOP’s as pertain to the sites Ensure that site has the equipment necessary to safely perform job responsibilities and is kept clean and organized
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
Other Responsibilities:
Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
Collaborate and communicate with other departments regarding inter-site issues
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
Certifications/Licenses, Education, and Experience
Bachelor’s Degree or equivalent professional experience
Research Professional Certification
A minimum of 3 years of clinical research experience
A minimum of 2 years prior Clinical Research Coordinator experience preferred
Previous Research Site Management experience preferred
How We Work Together
Location : This is an on-site position with regional commute requirements
Travel : This role requires up to 10% travel; requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of travelrequired: Regional (within 100 miles)
Physical demands associated with this position Include : The ability to use keyboards and other computer equipment. Walking, Standing, Sitting, Lifting (up to and over 25 lbs. and overhead), and Driving - 20% each
The expected pay 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
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.