Senior CRA, China, Hongyi Team
Indexed description
With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.
Global Expertise. Local Insight. Real Impact.
Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.
Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.
About The Role
The Senior Clinical Research Associate I (Sr. CRA I) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements
Responsibilities
- Implements and monitors local/global clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- Provides regular site status information to team members, trial management, and updates trial management tool
- Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
- Performs essential document site file reconciliation, manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial
- Performs source document verification and query resolution
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
- Be assigned logistical support tasks by PM for Investigator Meetings
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members as directed by study management
- Serves as observation visit leader of CRA level 1 and 2
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
- 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); or equivalent work experience required
- 4 years of local trial experience and/or minimum of 2 years of global trial experience
- Knowledge of ICH and local regulatory authority regulations regarding drug or medical device
- Experienced in CTMS, e-TMF, EDC, IVRS/IWRS system
Here’s What Makes Us Stand Out
- Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
- Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
- Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.
- Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
- Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
- Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
- Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
- Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.
We are an equal-opportunity employer and encourage applications from all qualified candidates.
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