Covance Clinical Research Associate II in Shanghai, China

Job Description:

Are you a Clinical Research Associate who wants to work with one of leading global CROs in the industry? Covance is seeking CRAs with at least 1 year clinical monitoring experience NATIONWIDE, and has a variety of CRA needs in Phase II-IV and Phase I (Early Clinical Development) in multiple therapeutic areas such as oncology, cardiovascular, diabetes mellitus, endocrinology, etc. Whether you’re ready to make a move or just interested in learning more, apply TODAY and let’s talk together!

Covance China is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Trial Operations Team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies.

Responsibilities/Duties:

Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Responsibilities and duties include, but are not limited to the following:

• Take charge of all aspects of Site Management as prescribed in the project plans.

• Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.

• Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned.

• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.

• Assist with training, mentoring, and development of new employees, e.g. co-monitoring.

• Perform other duties as assigned by management.

Education/Qualifications:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

Experience:

In lieu of the above requirement, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

• Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.

• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

• CRA II positions require 2+ years of clinical research monitoring experience

• Senior CRA positions require 4+ years of clinical research monitoring experience. Alternatively candidates with 4+ years supervisory experience in a health care setting and 3+ years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may also be considered.

Preferred:

One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. More years of experience preferred if apply senior level CRA positions.

About Covance:

Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 11,000 employees in 60 countries. We began operations in Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Why Covance China?

At Covance China, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance China, 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.

We Offer

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance China, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

There is no better time and choice to join us!

Requisition ID: 69575BR

Job Category: Clinical Research Associate

Locations: China - Shanghai

Shift: 1

Job Postings: Are you a Clinical Research Associate who wants to work with one of leading global CROs in the industry? Covance is seeking CRAs with at least 1 year clinical monitoring experience NATIONWIDE, and has a variety of CRA needs in Phase II-IV and Phase I (Early Clinical Development) in multiple therapeutic areas such as oncology, cardiovascular, diabetes mellitus, endocrinology, etc. Whether you’re ready to make a move or just interested in learning more, apply TODAY and let’s talk together!

Covance China is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Trial Operations Team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies.

Responsibilities/Duties:

Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Responsibilities and duties include, but are not limited to the following:

• Take charge of all aspects of Site Management as prescribed in the project plans.

• Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.

• Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned.

• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.

• Assist with training, mentoring, and development of new employees, e.g. co-monitoring.

• Perform other duties as assigned by management.

Education/Qualifications:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

Experience:

In lieu of the above requirement, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

• Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.

• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

• CRA II positions require 2+ years of clinical research monitoring experience

• Senior CRA positions require 4+ years of clinical research monitoring experience. Alternatively candidates with 4+ years supervisory experience in a health care setting and 3+ years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may also be considered.

Preferred:

One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. More years of experience preferred if apply senior level CRA positions.

About Covance:

Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 11,000 employees in 60 countries. We began operations in Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Why Covance China?

At Covance China, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance China, 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.

We Offer

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance China, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

There is no better time and choice to join us!

Education/Qualifications: Required:

•University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

•In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered

•Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements

•Thorough knowledge of monitoring procedures

•Basic understanding of the clinical trial process

Preferred:

•Thorough knowledge of Covance SOPs for site monitoring

Experience: Required:

•Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)

•Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

•Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

•Good planning, organization and problem solving abilities

•Ability to work with minimal supervision

•Good communication and interpersonal skills

•Good analytical and negotiation skills

•Computer competency

•Fluent in local office language and in English, both written and verbal

•Works efficiently and effectively in a matrix environment

Preferred:

•One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.