Clinical Research Manager

Job Summary

• The clinical research Manager oversees and performs clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, ISO standards, local regulations, and Genabio’s SOPs. This position will develop and maintain collaborative relationships with investigational sites and work closely with project management and Regulatory functions to identify and escalate risks of patient safety and data integrity.

Duties, Activities, and Responsibilities

• Conducting site qualification, initiation, interim monitoring and close-out visits.
• Documenting results of visits in monitoring reports for review and finalization.
• Facilitating IRB submissions and renewals when needed.
• Collecting and reviewing trial master documentation.
• Motivating investigational sites to close queries and actionitems.
• Maintaining contact with research site personnel over the life of a trial, including staffing changes and handling training or retraining.
• Contributing to study plans, site trackers, reports, and routine meetings.
• Ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Assisting QualityAssurance with SOP revisions, audits, and inspections.
• Additional tasks not described as assigned.

Education and Experience

• A Bachelor’s degree or equivalent in a life sciences, nursing, or related discipline.
• Minimum 5 years of clinical research experience for medical device and IVD products.
• Alternatively,equivalent combination of education, training and experience in a life science environment with work in clinical trials.

Knowledge, Skills, and Abilities

• Continuous learning and training on ICH GCP, FDA, and ISO regulatory guidance.
• Excellent professional written and verbal communication skills.
• Excellent time management skills and attention to details.
• Ability to write and modify SOPs,work instructions, forms, and templates.