Navitas Life Sciences Company Limited

Senior Clinical Research Associate/ Clinical Research Associate

Navitas Life Sciences Company Limited
Posted on 21-Apr-21

Senior Clinical Research Associate/ Clinical Research Associate

Navitas Life Sciences Company Limited

Job Highlights

  • 3+ years of on-site monitoring experience
  • CRA
  • Bachelor's degree in a health care

Job Description

Highlight:

  • CRA
  • 3+ years of on-site monitoring experience

Responsibilities:

  • Working in accordance with ICH E6 principles and with applicable SOPs (either Navitas Life Sciences or Sponsor's SOPs) & local regulatory norms
  • Review of study synopsis
  • Site selection
  • Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
  • Preparation, conduct and reporting of site selection visits
  • Negotiation & obtaining Investigator agreement on site budget, payment to the sites
  • Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
  • Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
  • Maintenance of TMF and Site specific file
  • Scanning & uploading documents into shared drive
  • Transmission of documentation into project files
  • Preparation of regulatory dossier, regulatory submission and follow-up.
  • Preparation of EC dossier, EC submissions and follow-up
  • Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
  • Development of meeting materials along with required presentations for investigators meeting.
  • Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
  • Co-ordinating  the IP request between sites and pharmacist/vendor/sponsor
  • Site monitoring visit planning, preparation, conduct, report and follow-up of pending issues
  • Remote Monitoring, Central Monitoring and Risk Based Monitoring related activities
  • Accompanied visit as a part of mentoring a new CRA
  • Interacting with DM for data transfer and query resolution
  • Interacting with MW for CSR appendices
  • Preparation of project status report.
  • Preparations, participation in meetings and documention of meeting minutes
  • Provide oversight to project (maintaining quality & timelines of deliverables)
  • Participate in client QA assessments.
  • Reconciliation Filing of project correspondence.
  • Site close-out visit planning, preparation, conduct, report.
  • Maintenance of Investigator database and a QC of the database
  • Archival of study documentation
  • Participation in other department initiatives/activities.

Requirement:

  • Bachelor's degree in a health care or other scientific discipline or educational equivalent.
  • Experience of ≥ 3 years of on-site monitoring experience; or equivalent combination of education, training and experience in clinical research
  • Good knowledge of Thai and international clinical research regulations and guidelines such as GCP principles and related local regulations
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Good communication and presentation both written and spoken in Thai and English
  • Good organizational and problem-solving skills
  • Effective time management skills
  • Good management skills
  • Ability to travel
  • Able to work independently as well as part of a team

Job details

  • Employment: Full-time
  • Type of Job: Clinical Research Development

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
N/A
Job Type
Full Time, Permanent

Company Overview

Navitas Life Sciences delivers platform-driven full-service Clinical, Regulatory, and Safety solutions and services. As the dedicated life sciences brand of TAKE Solutions, Navitas Life Sciences operates across North America, Europe, Asia Pacific, and Latin America. Navitas brings together the capabilities of a full-service CRO, a technology-led life sciences services provider, and expertise in analytics and data sciences to address critical challenges and drive outcomes for life sciences.

Navitas has over 30 years of rich experience across 550+ phase I-IV clinical trials, 1100 bioequivalence studies, 20+ therapeutic areas, and 40+ successful GCP/non-GCP audits. Our trial expertise is augmented by OneClinical, a platform that delivers trial oversight, analytics, and insights to drive successful study outcomes. With over 50 strategic regulatory consulting engagements, Navitas has delivered 170,000+ submissions to a range of regulatory authorities across the globe.

Backed by insights derived from our proprietary industry networks, and over 300 strategic safety consulting engagements, Navitas supports both in-trial and post-authorization pharmacovigilance to ensure better patient safety. Over the last 17 years, our 10 proprietary industry networks have provided a platform for industry peers to share with and learn from each other. With over 120 members, the ‘nets’ drive the development and adoption of industry best practices and innovations.

Navitas Life Sciences brings together the best minds in the industry to provide life sciences companies with an adaptive, innovative, and reliable partner who delivers better outcomes consistently, across the value chain.

Company Website:http://www.navitaslifesciences.com

Additional Company Information

Industry
Research / Survey