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.