Senior Clinical Research Associate - Long Term Follow-Up(Ltfu) (Remote)

at Merck in Boise, Idaho, United States

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager, taking overall responsibility of allocated sites.

Actively develops and expands the territory for Clinical Research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to:

+ 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.

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 and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation.

+ 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.

+ Support Oncology studies in Follow Up and Survival Follow Up.

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 (Must have in certain countries).

Qualifications, Skills & Experience

CORE Competency Expectations:

+ 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 analyse 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.

Behavioural Competency Expectations:

+ 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.

Experience Requirements:

Required:

+ Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

Preferred:

+ B.A./B.S. with strong emphasis in science and/or biology.

MRLGCTO

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NOTICEFORINTERNALAPPLICANTS

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.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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