Job Profile Clinical Research Quality Specialist (Offshore)
Department
Legal Operations (Offshore)
Location
Hyderabad
Reporting to
Manager, Clinical Research Quality (Offshore)
Hours of availability
Must, at minimum, be available to work eight (8) hours, Mondays-Fridays
(excluding company holidays) in alignment with typical USA working hours in at
least one of the following time zones: EST, CST, PST. Scheduling to be
supervised by, and in conjunction with, the Manager, Legal Operations
(Offshore).
Job role
The Clinical Research Quality Specialist will report to the Manager, Clinical
Research Quality. This individual will collaborate with the operations team
and firm practices to support clinical research across the firm network. The
Clinical Research Quality Specialist is a vital member of the research team
responsible for ensuring adherence to quality standards, regulatory
requirements, and best practices throughout the lifecycle of clinical trials.
This position requires a keen eye for detail, strong analytical skills, and a
deep understanding of clinical research processes and regulations. The
Clinical Research Quality Specialist works closely with cross-functional teams
to support quality management initiatives, conduct audits, and drive
continuous improvement efforts to enhance the overall quality and integrity of
clinical research activities.
Key responsibilities
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Assist in the development, implementation, and maintenance of quality
management systems to ensure compliance with regulatory requirements,
industry standards, and organizational policies
-
Participate in the development and review of standard operating procedures
(SOPs), work instructions, and quality documents to promote consistency and
compliance in clinical research operations
-
Conduct routine reviews and assessments of clinical trial documentation,
data, and processes to identify areas for improvement and ensure accuracy,
completeness, and compliance
-
Stay informed about current regulatory guidelines and requirements from FDA,
EMA, ICH, and other relevant regulatory authorities
-
Assist in the interpretation and implementation of regulatory requirements
to ensure adherence to applicable laws and guidelines throughout the
clinical research process
-
Support regulatory inspections, audits, and inquiries by preparing
documentation, facilitating site visits, and addressing findings as needed
-
Assist in developing training materials and resources on best practices in
clinical research
-
Participate in the delivery of training sessions to clinical research staff
to enhance their understanding of quality standards, regulatory
requirements, and organizational policies
-
Provide guidance and support to clinical research personnel on
quality-related issues, procedures, and documentation requirements
-
Assist in the planning, execution, and follow-up of internal and external
audits
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Prepare audit plans, checklists, and reports to document audit findings,
observations, and recommendations for corrective and preventive actions
-
Assist site research staff with process improvement needs identified through
audits
-
Collaborate with stakeholders to track and monitor the implementation of
corrective and preventive actions to address audit findings and ensure
compliance with regulatory requirements
-
Maintain accurate and comprehensive documentation of quality assurance
activities, audit findings, corrective actions, and preventive measures in
accordance with established procedures and timelines
-
Prepare periodic reports and metrics to communicate the status of quality
management activities, compliance initiatives, and audit outcomes to
relevant stakeholders and management
Key competencies
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Demonstrated problem-solving and analytical capabilities
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Solid understanding of Good Clinical Practice (GCP) guidelines, FDA
regulations, and other applicable regulatory requirements governing clinical
research
-
Strong attention to detail, analytical skills, and problem-solving
abilities.
-
Excellent communication, interpersonal, and organizational skills
-
Ability to work independently and collaboratively in a fast-paced,
team-oriented environment.
-
Ability to work cross-functionally to deliver on key initiatives
Qualifications and skills required
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Minimum of 2-3 years of experience in clinical research, quality assurance,
or regulatory affairs
-
Bachelor’s degree in a relevant scientific discipline required
-
Proficiency in Microsoft Office applications and familiarity with electronic
data capture (EDC) systems and clinical trial management systems (CTMS)
preferred
- Ability to travel ~25%
-
Bachelor’s degree in a relevant scientific discipline required