Covance

Clinical Study Start-Up Specialist (RSU / SSU Associate)

Job Location(s) KR-Seoul
Job Number
2021-75744
Job Category
Clinical Study Start Up
Position Type
Full-Time
Telecommute
No

Job Overview

Are you ready to discover you next career at Covance by Labcorp?
We are seeking an exceptional person with study start-up experience that is focused on advancing their career in Clinical Research to the next level.
 
Our Clinical Research Study Start-up Specialist provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in Korea. From our office in Seoul you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.
 
Joining us as a Start-up Specialist you will:
- Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.
- Participate in team meetings to progress trials and identify site issues that might impact the timelines.
- When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
- Liaise with Covance Regulatory department regarding document submission requirements, if applicable.
- Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
- May support the negotiation of site contracts and budgets with sites, if applicable andtrack progress of contract and budget milestones/developments, intervening and escalating as appropriate.
 
Covance by Labcorp is committed to providing employees the freedom to grow careers across all phases and areas of clinical trial operations as well as provide regular support to develop your experience even when you are based at a client site.
About Covance by Labcorp:
Covance by Labcorp is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Why Covance by Labcorp?
At Covance by Labcorp, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing
Covance by Labcorp, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
 
Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.
 
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Education/Qualifications

- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.

Experience

- Minimum of 2 years of experience in clinical development or start up/ regulatory process.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

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