Clinical Research Associate (I, II, Senior)

KCR Placement is a full-service functional sourcing and recruitment provider. We specialize in high-speed and high-quality talent sourcing for the CRO, Pharmaceutical, Biotech and Medical Device industries across Europe. 
Our employees are KCR Placement's most crucial asset. We commit to placing our candidates at the center of all we do and prepare them for long-term career development and success with competitive benefits and vibrant work environment. 
The KCR Placement team is supported by a specialized referral network of expert professionals and is dedicated to providing sourcing services and client support from job requisition to job offer. 

Clinical Research Associate (I, II, Senior)

With new trials and client portfolio development of interesting studies, we are expanding our CRA team allocated to a Sponsor (FSP Services).

Location: Poland (remote)

Duties associated with the role include:

• Duties associated with the role include:
  
• 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.
• Performs 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.
• Performs co‐monitoring as appropriate.

Requirements:

• B.A./B.S. preferred with strong emphasis in science and/or biology.
• Min. 1 year of direct monitoring experience.
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Excellent 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.
• Valid Category B driver's license.
• Demonstrated ability to mentor/lead.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• 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.
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of managing complex issues, working solution-oriented.
• Performs root cause analysis and implements preventative and corrective action.

To show that you are appreciated in our team, while working at KCR you will be provided with:

• 1 additional day off for your birthday;
• Private medical healthcare;
• Sport card;
• Loyalty Bonus Program (anniversary awards or additional paid time off);
• Additional days off during the end of the year;
• Employee referral system;
• 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.

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KCR is an equal opportunity employer providing its staff with excellent opportunities to build dynamic, long-term careers.