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 the human behind every number. 

Research Scientist

Conduct clinical research site management for KCR Placement.

• Acts as primary site contact and site manager throughout all phases of a clinical research study
• 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
• 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
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close‐out visits
• 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

Clinical Research Associate II - Senior Clinical Research Associate

Seeking a Clinical Research Associate for oncology trial monitoring and project management.

• Performing site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines and other applicable requirements.
• Ensuring overall integrity of study and adherence to guidelines, protocol and regulations.
• Taking an active role in the project team by providing feedback and suggestions for successful completion of the project.
• Leading, coaching and mentoring CRAs team to assist in their development and training.
• Responsible for execution of KPI`s for assigned staff and for all site deliverables within required time and budget.
• Providing leadership for the development and implementation of new training programs and improvement of current programs for assigned staff.

Senior Clinical Research Associate - Oncology Experience Required

Manage clinical research sites for KCR's clinical trials across Europe.

• 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.

Clinical Research Associate - I, II, Senior

Clinical Research Associate for Oncology with KCR's clinical development solutions.

• Perform site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines and other applicable requirements.
• Ensure overall integrity of study and adherence to guidelines, protocol and regulations.
• Provide feedback and suggestions for successful completion of the project.
• Lead, coach and mentor CRAs team to assist in their development and training.
• Responsible for execution of KPI's for assigned staff and for all site deliverables within required time and budget.
• Provide leadership for the development and implementation of new training programs and improvement of current programs for assigned staff.

Remote Jobs at KCR