Description
Duties* Assist in managing all aspects of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
* Perform the activities of planning, implementing, monitoring and the management and tracking of clinical trials
* Assist in the supervision of internal Clinical Support Team and Contract Research Organizations.
* Maintain contact with clinical investigators and staff to ensure compliance with protocols and overall clinical objectives.
* Participate in the design and development of clinical trial protocols and case report forms.
* Assist in the preparation of clinical study reports and annual reports.
* Work with data management to resolve data discrepancies.
* Perform other duties as assigned by management.
Experience
* Three plus years as a Clinical Research Associate.
* Demonstrated management of CRAs and Contract Research Organizations a plus.
* Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
* Demonstrated proficiency in the implementation, monitoring and management of clinical trials.
* Proficient in Excel, Word, and PowerPoint
Education
* Bachelor's degree in a scientific discipline or health-related field preferred
Other Knowledge And Skills Required:
* Clear and concise verbal and written communication skills.
* Strong organizational skills and attention to detail.
* Ability to handle multiple tasks simultaneously.
* Ability to prioritize.
* Ability to work quickly and accurately in a fast-paced environment
* Willingness to go beyond the scope of the job to help the department achieve its objectives.
* Dedication to quality and reliability in all work tasks.
* Self-motivation, eagerness to grow professionally and commitment to self-development.
* Willingness to travel (up to 50%) as necessary, consistent with the project needs.