As a Clinical Research Monitor (CRA) at InGeneron, Inc. you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. We are looking for an experienced, organized, flexible CRA to primarily be responsible for ensuring that all research being conducted is regulated and meets all the standards and policies of the company, and they work closely with researchers and other personnel to ensure data collected in the clinical trials are reviewed and verified .
- Manage Essential Documents by evaluation of the conduct of a trial and the quality of the data generated and good documentation practices
- Study Start-Up Assisting in feasibility assessment, site selection, pre-study visit, site initiation, subject recruitment and retention, trial master file (TMF) and clinical trials budgeting.
- assist sites in adhering to FDA and other local and international regulations and/or guidelines
- CRF review and source data verification, drug accountability and compliance, document archival and maintenance.
- Safety Reporting and compliance for adverse event reporting
- Be involved in study startup (if applicable)
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
Qualifications and Skills
- Minimum 5 years’ experience in monitoring, focus on orthopedics
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Experience in all types of monitoring visits in Phase and/or III
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Valid driver’s license (if applicable)Proficient computer skills.
- Valid driver’s license with up-to-date insurance.
- Excellent communication skills, using diplomacy and discretion.
- Professional demeanor.
- Excellent organizational skills.
- Remote Position
Please e-mail your resume to firstname.lastname@example.org or contact us at any time if you have questions.