Clinical Research Associate

Data: 2019-02-12

Location: Warsaw, PL

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Requisition ID: CLI008291

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.


 


MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our research division is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.


 


Position Overview          


 


The role is accountable for performance and compliance for assigned protocols and sites in the 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.


Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.


 


 


Major Activities


 


Description of Roles and 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



  • 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, and RCPM.



  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.



  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.



  • Supports and/or leads audit/inspection activities as needed.

 

Qualifications

Expertise Required / Core Competences  


 


Qualifications


Experience Required:




  • Min. 1-2 years of direct site monitoring experience in a bio/pharma/CRO.

 


Educational Requirements:




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

 


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.



  • 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 Clinical Research Guidelines and ability to work within these guidelines.



  • Hands on knowledge of Good Documentation Practices



  • Proven Skills in Site Management including 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

 


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



  • Travel



  • Ability to travel domestically and internationally approximately 30%-50% of working time. Expected travelling ~1-2 days/week.



  • Current driver’s license preferred.

 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Clinical Research - Clin Ops
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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