What We Do
Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Site Manager is responsible for overseeing the day-to-day activities at the site under the direction of the Country Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to local regulations and CARE SOPs in all aspects of conducting clinical trials.
What You'll Be Working On
Duties include but not limited to:
In this role, you will play an important role in ensuring high medical standards at Przychodnia Care Access Warszawa
Personnel:
· Meet with team members face-to face (at least monthly):
o Ensure regular site meetings with clear communication pathways are in place
o Skip level meetings with Warsaw site staff to ensure 360 feedback and communication regarding the site performance and management
· Interview and hire new staff members as needed
o Collaborate with Training Manager to train/onboard new site employees, as well as ensure completion of new employee paperwork and processes
o Work with site staff to set-up training plan based on prior experience
· Ensure HR policies are implemented and maintained at all sites
· Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year with Warsaw site employees to discuss progress
· Assure that all staff are up to date on annual training and documentation is in their record
· Encourage a positive team-oriented environment
· Lead by example and display high level of integrity and professionalism
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 Country Manager to identify outside vendors and set-up agreements
· Access and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
Increase the number of potential PI / Sub-I and Doctor Referrals working with Care Access is sufficient and allows achieving goals
-Maintaining relationships with physicians’ network that create expansion opportunities (PI’s, Sub-I’s, doctor referral)
· Assure study required training has been completed by staff and PI in a timely manner as to not delay study start up
· Update Country Manager on all pending and active study details
· Oversee all CRC’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained on a timely basis
· Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality at each site in the region. Work with Country Manager as processes may be implementable
· 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
Financial:
· Works closely with the Country Manager to ensure the timely responses to feasibility questionnaires and scheduling of Site Evaluation Visits as appropriate
· Perform a thorough review of protocols for needed outsourcing procedures and unusual procedures that require increase in costs/time of staff to complete
· Keep Country Manager of any study changes and all study related issues that affect the revenue generation at the site
· Work with CARE management to identify and communicate staff needs as appropriate
Site Maintenance:
· Keep Country Manager apprised of any site maintenance issues
o Coordinate building and equipment maintenance
· Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives
· Assure staff are following guidelines and SOP’s as pertain to the sites
o Ensure that site have the equipment necessary to safely perform job responsibilities
o Work with the Country 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
Physical and Travel Requirements
· Work is at the site, traveling will be only occasional
What You Bring
Knowledge, Skills, and Abilities:
· Excellent working knowledge of medical and research terminology
· Excellent working knowledge of regulatory, good clinical practices (GCP)
· Ability to communicate and work effectively with a diverse team of professionals
· Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments
· Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
· Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
· Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS word and excel
· Ability to balance tasks with competing priorities
· Critical thinker and problem solver
· Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
· High level of self-motivation, energy and possess a high degree of urgency
· Ability to work independently in a fast-paced environment with minimal supervision
· Ability to adapt to changes in responsibilities and workloads
· Must have a client service mentality
Certifications/Licenses, Education, and Experience:
· Master's degree required 2+ years proven experience in the management of a clinical research site/clinic/hospital department conducting clinical trials
-Strong organizational and planning skills to maintain a busy and diverse work schedule
-Fluent Polish and good command of English
-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
Benefits:
● PTO/vacation days, sick days, holidays.
● LuxMed
● PPK Plan
● Life Insurance
● Health & Wellness Allowance
● Bonus system based on achieving site goals
● Culture of growth and equality
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
What We Do
Care Access is a leading decentralized research organization (DRO) that breaks down traditional barriers in clinical research for patients, sponsors, and physicians. Its innovative model brings decentralized trials, Sites On Demand™, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster.
To find out how Care Access is transforming the future of clinical trials, visit www.careaccess.com or email [email protected].