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- West Region(REMOTE) at Merck in Boise, Idaho, United States Job Description Job Description The role is accountable for performance and compliance for assigned protocols and sites in a country.
- Using various tools to ensure:
- Ability to travel domestically and internationally approximately 65% 75% of working time.
- Current driver's license preferred (Must have in certain countries).
- Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
- B.A./B.S. with strong emphasis in science and/or biology. MRLGCTO #EligibleforERP NOTICE FOR INTERNAL APPLICANTS 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 ca To view full details and how to apply, please login or create a Job Seeker account
Senior Clinical Research Associate- West Region(REMOTE) - Boise, United States - Idaho State Job Bank
Description
Senior Clinical Research AssociateActs as primary site contact and site manager throughout all phases of a clinical research study, 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. + Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. + Participates & provides inputs on site selection and validation activities.
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.
Behavioral 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:
Educational Requirements:
Preferred: