Clinical Research Associate/Senior - China - Remote

Clinical Monitoring 31


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. 

We’re looking for an exceptional Clinical Research Associate/Senior - China  to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

At Premier Research, we are science-minded and heart-centered. Join us.

Clinical Research Associates are accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.

#LI-JD1

What you'll be doing:

  • Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
  • Maintains submission of expenses according to travel and expense requirements within company guidelines
  • Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
  • Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
  • Plans day to day activities for monitoring of a clinical study and sets priorities per site
  • Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
  • Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
  • Monitors with knowledge of quality/scope/timeline and budget parameters 
  • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member.  Escalates appropriately and in a timely manner to the appropriate team member
  • Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) 
  • Reviews site documents and verifies they are accurate, complete, current, and include required updates
  • Maintains project tracking system of subjects and site information, as applicable
  • Participates in Investigators’ Meeting as designated by the Project Manager
  • Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
  • Completes timely entry of hours worked and project codes per time entry guidelines
  • Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
  • Participates in available training offered to increase therapeutic knowledge
  • Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
  • In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
  • Acts as a resource for other CRAs and shares knowledge base and best practices

You will need this to be considered:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse)
  • Min. 2 years of  clinical monitoring experience
  • Fluency in English language
  • At least 2+years’ experience in clinical trials
  • Knowledge of ICH / GCP regulations
  • Knowledge of clinical/health systems as well as knowledge of cultural/professional practices 
  • Excellent team player, collaborative and able to enable an effective team
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication skills
  • Excellent organizational and time-management skills, able to meet deadlines
  • Maintains a positive, results orientated work environment
  • Valid driver’s license, passport as required