at Merck in Dover, Delaware, United States
Job Description
Job Description
With support of Sr CRA (Clinical Research Associate) 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:
+ Data generated at site are complete, accurate and unbiased
+ 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 (Clinical Research Manager), TA Head and CRD (Clinical Research Director) as needed.
+ Works in partnership with GCTO (Global Clinical Trial Operations) 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.
Extent of Travel:
+ Ability to travel domestically and internationally approximately 65%-75% of working time.
+ Expected travelling ~2-3 days/week.
+ Current driver’s license preferred.
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.
Requirements:
+ B.A./B.S. required with strong emphasis in science and/or biology.
+ Min. 2 years of clinical research experience. Related CR (Clinical Research) experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC (Clinical Trial Coordinator) or similar.
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In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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