Resolian - Your global bioanalytical, biomarker and analytical sciences partner supporting all phases of your drug development. Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science. Its team of more than 400 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies' programs throughout the entire drug development continuum.
About the role:
The Site Training & Development Coordinator is responsible for developing, implementing, coordinating, and continuously improving a comprehensive site-wide training and development program within a regulated Contract Research Organization (CRO) environment. This role supports the growth, competency, and compliance readiness of employees across laboratory operations, sample management, project management, quality, scientific, operational, and support functions.
The coordinator serves as the central point of accountability for training governance, onboarding, role-based qualification programs, competency assessment, leadership development, and continuous learning initiatives. Working closely with department leaders, Quality Assurance, Human Resources, and Subject Matter Experts (SMEs), this individual designs and maintains training systems that support employee development, operational excellence, regulatory compliance, inspection readiness, and organizational growth.
This role offers the opportunity to build and mature a best-in-class training culture by establishing scalable learning frameworks, career development pathways, and site-wide competency programs that enhance employee engagement and business performance
Essential Functions:
Training Program Administration
- Coordinate onboarding and training activities for new laboratory employees.
- Maintain laboratory training curricula, qualification matrices, and competency assessments.
- Schedule, track, and document instructor-led, hands-on, and electronic training programs.
- Ensure training records are complete, accurate, and audit-ready.
- Monitor training completion and compliance metrics and provide regular status reports to management.
Compliance and Quality Support
- Ensure training programs comply with GLP, GCP, GMP, CAP, CLIA, ISO, and other applicable regulatory requirements.
- Support internal audits, client audits, and regulatory inspections by providing training documentation and records.
- Collaborate with Quality Assurance to address training-related observations, deviations, and corrective actions.
- Review and update training procedures to align with evolving regulatory requirements and laboratory processes.
Learning and Development
- Develop training materials, presentations, job aids, and standard operating procedure (SOP) training content.
- Support implementation and administration of Learning Management Systems (LMS).
- Facilitate classroom and virtual training sessions as required.
- Promote continuous learning and professional development within laboratory operations.
Cross-Functional Collaboration
- Work closely with laboratory managers, scientists, technical leads, Human Resources, and Quality Assurance teams.
- Coordinate training requirements related to new client studies, method validations, equipment qualifications, and process improvements.
- Communicate training expectations and compliance requirements to stakeholders.
Education
- Bachelor's degree in biology, Chemistry, Life Sciences, Medical Technology, Education, Training, or a related field preferred.
- Equivalent combination of education and experience may be considered.
Experience
- 3+ years of experience in laboratory operations, training coordination, quality systems, or a regulated healthcare/life sciences environment.
- Experience within a CRO, pharmaceutical, biotechnology, clinical laboratory, or diagnostic laboratory preferred.
- Experience managing training records and Learning Management Systems preferred.
Knowledge, Skills, and Abilities
- Working knowledge of GLP, GCP, GMP, CAP, CLIA, ISO 15189, or related regulatory requirements.
- Strong understanding of laboratory workflows, SOPs, and quality management systems.
- Excellent organizational and project management skills.
- Strong written and verbal communication skills.
- Ability to prioritize multiple projects and meet deadlines.
- Proficiency with Microsoft Office Suite and Learning Management Systems.
- Strong attention to detail and documentation accuracy.
Preferred Qualifications
- Certification in Training and Development, Quality Management, or Adult Learning.
- Experience supporting regulatory inspections and client audits.
- Experience developing laboratory competency programs and training curricula.
- Familiarity with electronic quality management systems (eQMS).