Clinical Research Associate

GENERAL ACCOUNTABILITY:

The Clinical Research Associate is responsible for facilitating the conduct of clinical research involving human subjects under the general direction of a Principal Investigator (PI) and the Provincial Leader of Clinical Trials. This would include and not be limited to: ensuring research trials are conducted efficiently, accurately and in compliance with Good Clinical Practice (GCP) guidelines, ensuring that submissions, revisions, amendments, safety alerts etc. are properly documented in a timely manner, and ensuring that all regulatory requirements for the Canadian Health Products and Food Branch (HPFB) and the US Food and Drug Administration (FDA) submissions are met.

QUALIFICATIONS:

Education:

• Diploma in Health Information Management OR Bachelor Degree in a health related field

Experience:

• One (1) year of clinical research experience in an environment involving direct patient care

OR

• Three (3) years of oncology experience as a health information practitioner

Membership:

• Certification with Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Candidates that do not have this credential at the time of application will be given two (2) years to obtain.

Skills:

• Ability to effectively analyze information, problems, situations, practices or procedures.
• Advanced knowledge of basic research principles involving human subjects.
• Ability to manage multiple tasks in various stages of completion according to priorities.
• Moderate judgment and problem solving skills are required to select the most appropriate action from a variety of alternatives.
• Ability to interpret detailed information and communicate effectively both orally and in writing.
• Human relations skills required to ensure compliance and promote acceptance through negotiating with staff and suppliers where there is a requirement to resolve the conflict or situation.
• Proficiency with a variety of computer systems and software applications.
• Maintain confidentiality.
• Knowledge of culturally responsive care for First Nations and Métis people.