Labcorp, a global leader in clinical trial services and laboratory testing, is currently hiring for the position of Informed Consent Codification Associate in Bangalore, India. This role is ideal for individuals looking to build a career in clinical research and regulatory affairs.
Role Overview
The Informed Consent Codification Associate is responsible for ensuring that informed consent documents comply with regulatory standards and are properly codified across multiple client instances. The role involves reviewing, analyzing, and troubleshooting errors in informed consent forms (ICFs) while ensuring accuracy and adherence to compliance requirements.
Informed Consent Codification Associate
Category: Clinical
Location : Bangalore, India
Job ID : 256171
Job Type : Full-Time
About the job
Function Specific
Perform informed consent codification across multiple client instances.
Informed consent codification executed to completion correctly
Delivery schedules are met.
Strong troubleshooting and analytical skills for the identification of errors and resolution steps.
Triages unacceptable errors for resolution
Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
Metrics
Support management of metrics.
Assist with investigating or resolving issues of quality as directed.
Process Improvement
Suggest process improvements where issues are seen.
Support Six Sigma process improvement teams.
Training / SOPs
Reviews training materials for staff.
Mentor and support other GSS employees in their understanding and adoption of Informed consent codification.
Other
Lead or assist with special projects as designated.
Perform other duties as assigned by management
Experience Recommended
0-1 year of experience working in clinical trials, laboratory, or specimen management
Knowledge of informed consent forms essential.
Experience writing, reviewing, or reading informed consent for clinical trials
Knowledge of global regulation and guidance documents in relation to informed consent information
Proven ability to plan, prioritize, and manage in a fast-paced environment with a high degree of initiative
Strong drive for process optimization and data integrity
Excellent communication and interpersonal skills with great attention to detail
Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO, or related industry.
Problem-solving/Logic Skills
Strong MS/Office skills in particular with Excel and Word.
Education/ Qualifications/ Certifications And Licenses Recommended
University/ College Degree degree preferably in the sciences or related field.
Why Join Labcorp?
Labcorp offers a dynamic work environment that supports professional growth and innovation. Employees have the opportunity to work on impactful clinical research projects while developing their expertise in regulatory compliance and data integrity.
How to Apply?
Interested candidates can apply through Labcorp’s career portal or visit careers.labcorp.com for more details.
