Clinical Research Associate II - Senior Clinical Research Associate

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 • 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

Requirements

• B.A./B.S. preferred with strong emphasis in science and/or biology • Min. 2 years of direct monitoring experience • Fluent in Local Languages and English (verbal and written) and excellent communication skills • 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 • Demonstrated ability to mentor/lead • Valid Category B driver's license • Hands on knowledge of Good Documentation Practices • Proven Skills in Site Management • Demonstrated high level of monitoring skill with independent professional judgment • Good IT skills and ability to adapt to new IT applications • 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 • 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 • Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.