We are looking to hire a CRA 1 (entry level) to perform and coordinate all aspects of the clinical monitoring process in compliance with ICH/GCP and other regulatory agency guidelines. Conduct site visits to determine protocol and regulatory compliance and prepare required documentation. Ensure that the data reported in site source documents is accurate, complete and verifiable. Maintain ongoing and continuous professional communication with the study team throughout the duration of the study. Willing and able to assist in other company projects, i.e. audits, clinical writing and quality work.
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.
Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant regulations.
Good understanding of Clinical Study Management.
Must be customer oriented and flexible.
Strong commitment to quality.
Strong attention to detail and accuracy.
Ability to travel as required, 50-70%.
Telecommuting is allowed.
Additional Salary Information: Benefits include: Vacation, Personal and Sick time, Health Insurance, Dental and Vision, Life Insurance, Disability and 401(k) Plan.