Clinical Research Associate I

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see human behind every number

Clinical Research Associate I

Location: Poland (remote) or Warsaw (hybrid/office-based)

We are currently looking for new team members who are interested in developing into the CRA role. Previous experience as a CRA isn’t required but a good knowledge of the industry and role would be an advantage. A full training and assessment program including opportunities to accompany experienced CRAs at site will be provided to successful candidates. This is an excellent opportunity to take an initial step into the clinical trial monitoring industry and to work with varied clients on interesting studies.

Detailed Job Duties and Responsibilities

• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Supports clinical study site management/monitoring activities in compliance with ICH‐GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in‐depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides input on site selection and validation activities.
• Performs remote and on‐site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased; subjects’ right, safety and well‐being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close‐out visits and records clear, comprehensive and accurate visit & non‐visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start‐up, study maintenance and study close‐out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, CRA‐M/PLM.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
  Supports and/or leads audit/inspection activities as needed.

Education / Qualifications / Skills Requirements

• B.A./B.S. preferred with strong emphasis in science and/or biology.
• Good knowledge about the industry and conduct of clinical trials.
• Direct monitoring experience would be an advantage.
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyze data/metrics and act appropriately.
• Capable of managing complex issues, working solution-oriented.

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.

To demonstrate how appreciated your talent and your commitment are, KCR is offering you:

• 1 additional day off for your birthday;
• Private medical insurance
• Sport card
• Referral program
• Loyalty bonus (anniversary awards or additional time-off)
• Onboarding process and induction training to develop deep sector knowledge and complex skills;
• Latest technology and the most advanced equipment and working tools;
• An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement;
• Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.

Our Privacy Policy

Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: Privacy Policy .

Providing your personal data is voluntary, however, if you do not provide us with the necessary information, we will not be legally allowed to get in touch with you and consider your application. By sending application documents containing your personal data to a wider extent than required by provisions of the applicable laws, you are granting consent for the data to be processed for the purposes of the ongoing recruitment.

If you would like your candidacy also to be considered for future recruitments, please select an additional consent or add the following statement to your application documents: “I agree to the processing of my personal data for any future recruitments conducted by KCR and/or KCR affiliates for a period of up to 3 years”. Such consent may be placed in your CV or electronic correspondence addressed to your potential employer.

You may withdraw any consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: Privacy Policy .

You can contact KCR Group Data Protection Officer at gdpr@kcrcro.com any time with any questions or concerns regarding how your personal data is processed.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

If you require reasonable accommodations to participate in the application process, please let us know by email: eeo@kcrcro.com. We are committed to ensuring equal opportunity for all applicants and will work to provide reasonable accommodations to support your needs.