Covance

Senior CRA

Job Location(s) SG-Singapore
Job Number
2020-53550
Job Category
Clinical Research Associates
Position Type
Full-Time
Telecommute
No

Job Overview

Responsibilities:
- Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
- Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
- General On-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
- Prepare accurate and timely trip reports
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms as assigned
- Responsible for all aspects of registry management as prescribed in the project plans
- Conduct, report and follow-up on Quality Control Visits (CQC) when requested
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
- Complete process of 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
- Other Ad-hoc projects when assigned

Education/Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
• In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
• Thorough knowledge of regulatory requirements
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
• Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Preferred:
• Thorough knowledge of company SOPs regarding site monitoring
 

Experience

 
- Minimum Two (2) years of Clinical Monitoring experience
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
Preferred:
- One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
- Local project coordination and/or project management experience
- Experience with oncology and/or Phase 1 will be preferred.

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