Senior Clinical Research Associate

Job DescriptionAre you an experienced Clinical Research Associate looking for a new opportunity to excel in your career? Join our dynamic team and make a difference in the field of Clinical Research. We are seeking a highly motivated and detail-oriented individual to oversee and manage Clinical Research protocols and sites in (country). As a Clinical Research Associate, you will play a crucial role in ensuring compliance with regulations, company policies, and quality standards.Responsibilities:Ø Develop strong site relationships and ensure continuity throughout all phases of the trial.Ø Perform clinical study site management activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, and protocol requirements.Ø Gain in-depth understanding of study protocols and related procedures.Ø Coordinate and manage tasks in collaboration with other sponsor roles to achieve site readiness.Ø Conduct remote and on-site monitoring activities to ensure data accuracy and subjects' safety.Ø Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.Ø Communicate with investigators and site staff on protocol conduct, recruitment, retention, and regulatory compliance.Ø Identify and resolve site performance, quality, or compliance issues in collaboration with relevant stakeholders.Ø Work collaboratively with internal teams and external partners in support of assigned sites.Ø Manage and maintain information and documentation in various systems.Ø Contribute to CRA team knowledge by acting as a subject matter expert, sharing best practices, and providing training as needed.Ø Support audit and inspection activities as required.Ø Contribute to the identification and development of new potential sites.Requirements:Ø Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.Ø Fluent in local languages and English (verbal and written) with excellent communication skills.Ø Excellent understanding of Clinical Research, GCP/ICH guidelines, and country-specific regulations.Ø Demonstrated ability to mentor and lead.Ø Strong IT skills and ability to adapt to new applications.Ø Ability to analyze data/metrics and take appropriate action.Ø Experience with site motivational visits to boost enrollment.Ø Capable of managing complex issues and implementing corrective action.Ø B.A./B.S. with strong emphasis in science and/or biology preferred.Why Join Our Team:Ø Opportunity to work in a dynamic and growing company at the forefront of Clinical Research.Ø Collaborative and supportive work environment.Ø Growth and development opportunities.Ø Competitive salary and benefits package.Ø Don't miss this chance to take your career to the next level. Apply now and be part of our team!Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 06/28/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.