Job Description

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.

• 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 at site 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 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 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.

Qualifications, Skills & Experience

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 of site 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.

Behavioral Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict

management

• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

• Works effectively in a matrix multicultural environment. Ability to establish and

maintain culturally sensitive working relationships.

• Demonstrates commitment to Customer focus.

• Positive mindset, growth mindset, capable of working independently and being self- driven.

• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Experience and Educational Requirements: - 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.

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