Clinical Research Associate - I, II, Senior

3 days ago

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KCR

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KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations.

Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs

501 - 1000

Description

• 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

Benefits

• 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