To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education/Experience: The ideal candidate will offer:
- Bachelor's degree (BA/BS) or nursing degree (associate of applied science or above). Clinical research or life science degree preferred. Advanced degree is preferred.
- Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
- Seven or more years of relevant experience required with at least two years of experience in a pharmaceutical/biotech company preferred.
- Prior supervisory or study management experience strongly preferred.
Knowledge, Skills and Abilities:
- Demonstrated in depth knowledge of GCP, ICH guidelines, and FDA regulations.
- Demonstrated ability to work independently and in a team environment.
- Proficiency with MS Office.
- Excellent oral and written communication skills and strong organizational abilities.
- Ability and willingness to travel 25% - 50% of the time (internationally and domestically).
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 25lbs, less than 25% of the time.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.