Clinical Research Associate

Job Description

Provide education and clinical support of R&D products and their applications. Have total familiarity with the Device GMP and GCP Regulations and the companies’ Quality Systems requirements and assures that these are followed. Have the basic critical care and technical skills to provide education and support to all clinicians and study subjects. Have knowledge and experience in monitoring clinical trials, data collection, writing protocols and test

reports.

• Assists to coordinate and conduct clinical training on test products

• Provides product evaluation support in hospitals and other medical facilities.

• Conducts house visits and reports findings

• Conduct study monitoring according to monitoring plan

• Complete required administrative activities

• Study data collecting and reporting

Required Experience & Skills:

•Ability to utilize/develop tools including email or any other means available to

effectively perform the required task(s).

• Ability to understand and escalate test subjects issues in a timely manner to

supervisor.

• Excellent follow through skills, interpersonal skills, hard working. Must have excellent

attention to detail and accuracy.

• Positive attitude, responsible, dependable, reliable and dedicated.

• Demonstrated excellence in organization and time management skills. Able to

perform multiple tasks efficiently.

• Strong data entry, written and verbal skills.

• Must be able to work independently and in a team environment.

• Ability to provide good customer service.

• Must be willing and able to perform field test and home visits.

• Must have thorough knowledge and experience in using the Microsoft Office Suite of

programs including Excel and Word.

• Experience in a Medical device environment preferred.

• Nursing experience in the critical care arena; including ED, CATH lab, ICU preferred.

Language Ability:

• English – high level

• Ability to read and interpret documents such as safety rules, operating and

maintenance instructions, and procedure manuals. Ability to write routine reports

and correspondence. Ability to speak effectively before groups of test subjects or

employees of organization.

Reasoning Ability:

• Ability to apply common sense understanding to carry out detailed written or oral

instructions. Works on assignments that are moderately complex in nature where

judgment is required in resolving problems and making routine recommendations.

Required Education:

• CRA certificate

• Bachelor's degree – B.Sc - advantage

• Commercial applications experience - advantage.