As a Clinical Research Associate 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 organized, flexible Clinical Research Associate to oversee clinical trials. The Clinical Research Associate will assist to establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The Clinical Research Associate will manage multiple aspects of subjects’ welfare. You will generate and distribute internal and external newsletters, prepare final reports and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records. To be successful in this role, you should be able to recognize logistical problems, and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask and be able to collaborate with various role players.
Duties and Responsibilities:
- 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
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Experience in all types of monitoring visits in Phase II 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.
About InGeneron Inc:
InGeneron was formed to innovate cell-based technologies for healthcare, veterinary and life science research. InGeneron’s advanced cell separation technologies enable preparation of adipose-derived regenerative cells, including stem cells, that have the potential to aid physicians and veterinarians in the treatment of a number of diseases, orthopedic injuries and cosmetic procedures. InGeneron is a privately held company, developing its own products for multiple markets and expanding its reach through licensing agreements. Its research and development capability span the disciplines of biomedical engineering, cellular as well as molecular biology, and pharmacology.
Interested candidates contact Samantha Pena at email@example.com.