Clinical Research Associate (m/w/d)

Datum: 16.05.2019

Location: Haar, BY, DE

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Requisition ID: CLI008557

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
 
The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally.
 
The CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 and CRM
  • 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
Qualifications

Experience Required
 
  • Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO
 
Educational Requirements
 
  • B.A./B.S. with strong emphasis in science and/or biology
 
Travel Expectations
 
  • Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week
  • Current driver’s license preferred
 
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
  • 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
 
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 mindset
 
We offer
 
  • An exciting opportunity within a stable and growing company
  • Development and career opportunities within the company
  • A competent, motivated and great team
 
Interested in becoming part of a dynamic, developing team and contributing your know-how to an innovative environment that allows you to show initiative and that offers long-term perspectives? Please apply using the link to our career site!

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.             


Job: Clinical Research Monitor
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 6
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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