Site Manager-Warsaw Poland

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 are not limited to:

1. Meet with team members face-to-face (at least monthly):
   1. Ensure regular site meetings with clear communication pathways are in place
   2. Skip level meetings with Warsaw site staff to ensure 360 feedback and communication regarding the site performance and management
2. Interview and hire new staff members as needed:
   1. Collaborate with Training Manager to train/onboard new site employees, as well as ensure completion of new employee paperwork and processes
   2. Work with site staff to set up a training plan based on prior experience
3. Ensure HR policies are implemented and maintained at all sites
4. Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year with Warsaw site employees to discuss progress
5. Assure that all staff are up to date on annual training and documentation is in their record
6. Encourage a positive team-oriented environment
7. Lead by example and display a high level of integrity and professionalism
8. Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
9. Coordinate Investigator and Sub-Investigator coverage
10. Work with Country Manager to identify outside vendors and set up agreements
11. Access and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
12. Maintain relationships with physicians' network that create expansion opportunities (PIs, Sub-Is, doctor referrals)
13. Assure study required training has been completed by staff and PI in a timely manner as to not delay study start-up
14. Update Country Manager on all pending and active study details
15. 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
16. 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
17. Attend all study audits and play an active role in their management and execution of follow-up items
18. Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
19. Work closely with the Country Manager to ensure timely responses to feasibility questionnaires and scheduling of Site Evaluation Visits as appropriate
20. Perform a thorough review of protocols for needed outsourcing procedures and unusual procedures that require an increase in costs/time of staff to complete
21. Keep Country Manager informed of any study changes and all study-related issues that affect the revenue generation at the site
22. Work with CARE management to identify and communicate staff needs as appropriate
23. Keep Country Manager apprised of any site maintenance issues
24. Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives
25. Ensure that staff are following guidelines and SOPs as pertain to the sites
26. Ensure that site has the equipment necessary to safely perform job responsibilities
27. Work with the Country Manager to review and address injury reports if necessary
28. Ensure the lab follows IATA guidelines and applicable staff are properly certified
29. 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:

1. Excellent working knowledge of medical and research terminology
2. Excellent working knowledge of regulatory, good clinical practices (GCP)
3. Ability to communicate and work effectively with a diverse team of professionals
4. Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others' work and follow through on assignments
5. Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
6. Work effectively and collaboratively with other team members to accomplish mutual goals
7. Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel
8. Critical thinker and problem solver
9. Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
10. High level of self-motivation, energy, and possess a high degree of urgency
11. Ability to work independently in a fast-paced environment with minimal supervision
12. Must have a client service mentality

Certifications/Licenses, Education, and Experience:

1. Master's degree required 2+ years proven experience in the management of a clinical research site/clinic/hospital department conducting clinical trials
2. Fluent Polish and good command of English
3. Proactive approach with the ability to work autonomously
4. Excellent problem-solving skills
5. The ability to multi-task and work well within a high-paced pressurized environment
6. Excellent communication skills paired with the ability to develop and nurture relationships
7. 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.