Clinical Research Associate

Location: Flemington, NJ

Supervised by: Project Manager and/or designee

Travel: Up to 70%

Overview of position: The CRA II will have extensive involvement with teaching and mentoring, site management, sponsor contact, etc., as outlined below. Position may require some management responsibilities.

Description:

A. Essential Functions:

• Conducts monitoring multiple study sites.
• Assess sites to identify root problems and resolve them.
• Coordinates departmental, project, and/or investigator meetings, as appropriate.
• Present information and data at investigator meetings as needed.
• Participate in the training of entry-level CRAs.
• Performs in-house data review functions.
• Drafts CRF Completion Guidelines

B. Non-Essential Functions:

• Makes presentations within the company on assigned drug, therapeutic area, and/or study results.
• Contributes to the review and/or design of protocols, CRFs, and Investigators Brochures.
• Assists the Project Manager in overseeing/coordinating project(s).
• Provide guidance and mentoring to other staff.
• Assist with special projects and other duties as required.
• Make 10 site visits a month and work on projects when not traveling; Ability to travel: up to 70%

Qualifications:

A. Skills:

• Must have experience with EDC systems.
• Ability to prioritize work in order to meet demanding timelines.
• Able to work in a fast-paced environment with changing priorities.
• Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
• Have an understanding of Good Clinical Practice regulations, ICH guidelines, and internal SOPs necessary to monitor a site.
• Ability to work independently as well as in a team matrix organization with little or no supervision.
• Excellent written and verbal communication skills.
• Detail oriented.
• Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus.

B. Educational Requirements:

• Bachelor’s degree in nursing, pharmacy, the life sciences, or a related health field or equivalent experience; BSN a plus.
• 3+ years experience in a pharmaceutical or biotechnology company or CRO as a CRA, with at least 1 year experience in field monitoring.

 

Please contact or fax your CV, with salary requirements and contact information to (908) 788-5281, ATTN: Human Resources.