Note: The job is a remote job and is open to candidates in USA. Merck is a leading biopharmaceutical company, and they are seeking a Senior Clinical Research Associate to oversee clinical study sites. The role involves ensuring compliance with regulations, developing site relationships, and managing various monitoring activities throughout the clinical research process.
Responsibilities
- 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: Data generated at site are complete, accurate and unbiased and 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 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
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required
- Supports and/or leads audit/inspection activities as needed
- Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate
- Could perform Quality control visits if delegated by other roles and trained appropriately
Skills
- CANDIDATE MUST RESIDE IN FLORIDA
- Early stage development experience required
- Ability to travel domestically and internationally approximately 65%-75% of working time
- Current driver's license required
- 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
- 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, also in a virtual environment
- Experience with conducting site motivational visit designed to boost site enrollment
- Capable of managing complex issues, works in a solution-oriented manner
- Performs root cause analysis and implements preventative and corrective action
- Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
- Able to work highly independently 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
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
- Demonstrates commitment to Customer focus
- Works with high quality and compliance mind-set
- 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
- Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO
- Or Bachelor's degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO
- Adverse Event Report, Biopharmaceutics, Clinical Data Management, Clinical Development, Clinical Research, Clinical Study Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Customer-Focused, Early Clinical Development, Preventive Action, Regulatory Affairs Compliance, Site Management
Benefits
- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
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