Opens fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com in a new tab. Check the address before sharing personal information.
Key skills in this ad
Skills and tools
Clinical research
Google Cloud
Business development
Picked out automatically from the employer's ad. Read the full description before applying.
About this role
Job Description
The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that are conducted in accordance with ICH guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Make job search work for you
Turn a broad, stressful search into a focused weekly routine.
Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs).
Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs.
Ensure safety issues are reported to the sponsor promptly. ü Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study, Support sites to be always audit and inspection ready.
Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data.
Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs.
Escalate all key issues as per Issue Escalation SOP.
Collaborate with IHCRA and Site Contract Associates, as applicable, on-site payments, taking ultimate responsibility on site payments to ensure payment execution as per term stated in Clinical Trial Agreement.
Assist the PM with the development of study related project plans and templates as per study requirements and support tasks as needed for successful study execution.
Demonstrate a thorough understanding of ICH GCP, The Declaration of Helsinki, and any local guidelines as they apply to the investigator, sponsor, monitor, and IEC.
Be aware of and adhere to company processes in areas relevant to a CRA. Be quality focused on the performance of duties. Assist in the review and development of clinical SOPs and processes.
Participate in activities of the Clinical Services Department, including presentations at clinical department meetings, and assisting with the development of clinical processes and SOPs.
In collaboration with Business Development (BD), foster relationships with sites to provide feasibility information, as requested, and in accordance with documented feasibility processes, Highlight any BD opportunities to the group.
Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company.
Qualifications
Graduate in a clinical or life sciences-related field.
Relevant experience/qualifications in allied professions may also be considered.
Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
Experience of working in the research, pharmaceutical industry or a related field
Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
Strategic vs transactional mindset.
Ability to gain insights and make proactive decisions quickly.
Culture that fosters partnership and collaboration, where every voice is heard and valued.
Ongoing support from senior stakeholders and leadership team.
.
Job Info
Job Identification
4734
Posting Date
11/12/2026
Apply Before
12/17/2026
Job Schedule
Full time
Locations ul. Marszałkowska 142, Warsaw, 00-061, PL
Healthcare
Science & research
Research
Pay
Pay is not stated in the ad.
Estimate take-home pay for a figure you enter
Estimated take-home pay
Explore gross pay after typical payroll taxes for a work location.
Illustrative estimate only; assumes a standard employee profile and may omit benefits, pensions, credits and local rules. Regional and city-specific tax applies only where the selected calculator supports it; other results are country-level. Salary and location are sent only when you calculate: Paysums for supported regions, or WorthOf for wider country coverage. Confirm with an official payroll or tax source before making decisions.
Visa sponsorship and relocation: not stated in the ad.
JobCheckPoint never asks candidates to pay, and genuine employers shouldn't either. If this job asks you for money (registration, training, visa or equipment fees), don't pay. Report it below.
