Clinical QA Lead

Job Title: Clinical QA Lead

Company: Clinical Research Organization

Location: Remote

Contract Length: 6-8 Months

Hours: 20-25 pw

Barrington James Recruitment has partnered with a global, full service CRO, specializing in qualifications in the development of therapeutic drugs. Industry leading services include Medical Monitoring, Project Management, Medical Writing, BioStatistics and Site Selection to name a few.

This truly exciting opportunity will be to Lead the build out of the departmental quality infrastructure for an established business, growing their US operations.

Responsibilities;

• Implements and maintains programs and processes to ensure high quality products and compliance with current Good Clinical Practices (GCPs). Supporting the identification and implementation of continuous improvement opportunities and initiatives. Execute the internal clinical quality audit plans. Serve as the primary developer of audit systems, plans and implementation methods for all departments. Develop, review and approve Standard Operating Procedures (SOPs)s to ensure operations are in compliance with regulations and unit policies and procedures. May lead the development of risk assessment tools. Determine and develop appropriate procedures and documentation to ensure standards, practices and policies and procedures are in compliance with applicable laws, regulations, requirements and standards and the associate follows these procedures or documents compliance with them through departments. Identify and assess quality assurance problems. Assist in the development of training programs including development and updating of training and procedural manuals. Ability to write reports, business correspondence, and procedure manuals. Remain abreast of current regulations and industry best practices in clinical trials.

Experience / Qualifications Required;

• 5+ years of experience in clinical research, biotechnology or other GxP environment specializing in Clinical Quality; traditional site experience a plus, both traditional and virtual site experience a major plus. Knowledge of cGXP regulations and current industry best practices Excellent written and oral communication skills Ability to meet deadlines in a fast-paced environment Bachelor’s Degree in science, engineering or other related field required