We are seeking a Clinical Trial Associate to become a part of our team! Under general supervision, reporting directly to VP of Clinical Research Operations. This position performs a supporting role in the financial and operational activities of the Clinical Research Department within the Houston Office
- Key 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
Qualifications and Skills
- 3-5 years of experience as a Clinical Trial Associate
- 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.
- 401K, Dental, Life, Medical, Vision
- At InGeneron Inc, Houston, TX
Please e-mail your resume to firstname.lastname@example.org or contact us at any time if you have questions.