Associate Clinical Research Associate

Job description

Job Description THE OPPORTUNITY With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. WHAT YOU WILL DO • 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 inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated atsite are complete, accurate and unbiased o 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 forstudy 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 CRA Manager, CRM, TA Head and CRD as needed. • Works in partnership 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 audit/inspection activities as needed. • Performs co-monitoring where appropriate. Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. • Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines. • Hands on knowledge of Good Documentation Practices • Developing skills in Site Management including management ofsite performance and patient recruitment • Developing level of monitoring skill and independent professional judgment. • Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. • Works with high quality and compliance mindset. • Capable of managing complex issues, solution-oriented approach. • Ability to perform root cause analysis and implement preventative and corrective action. WHAT YOU MUST HAVE • Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together with at least 3 years of relevant experience in the healthcare field. Or • Bachelor’s degree (or above) in a scientific / healthcare discipline together with at least 6 months of relevant experience in the healthcare field. or • Bachelor’s degree (or above) in a non-scientific/healthcare discipline together with at least 2 years of relevant experience in the healthcare field Required Skills: Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Early Clinical Development, Good Clinical Data Management Practice (GCDMP), Investigations Training, Key Stakeholder Relationships, Pharmaceutical Guidelines, Pharmaceutical Regulatory Affairs, Pharmacokinetics, Pharmacotherapeutics, Pharmacovigilance, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Root Cause Analysis (RCA) Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/31/2026*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.