Clinical Research Professional

Winnipeg Regional Health Authority•Winnipeg, MB

2d•Onsite

About The Position

CancerCare Manitoba is a provincial agency which provides clinical and academic services and leadership for cancer control and the treatment of blood disorders. Our shared vision of a world free of cancer drives every member of our team. CancerCare Manitoba is the perfect place to thrive if you're seeking a fulfilling career in an organization that is committed to its employees' well-being and professional development. Reporting to the Unit Manager, the Clinical Research Professional (CRP) functions as an essential member of the clinical research team. Responsibilities include but are not limited to screening and recruiting eligible participants for active research studies in accordance with protocol guidelines and regulatory requirements. The CRP will explain the study to participants and answer questions about non-interventional trials in order to obtain informed consent/assent, from patients and families (excluding interventional trials); The CRP will also ensure adherence to the study protocol by interpreting and abstracting health information to enroll eligible participants, preparing and shipping biological samples and radiographic images, and extracting, compiling, submitting, and retaining patient data for the duration of the study. The CRP will monitor study compliance, manage clinical trial patient files; communicate effectively with study sponsor representatives and members of the study team. The CRP will also be responsible for the preparation, submission, and follow-up of required committee and board approvals necessary for the conduct of clinical research. The CRP will serve as a liaison with appropriate departments and external agencies to ensure the smooth and ongoing operation of the research project. The CRP must be knowledgeable in clinical trial regulations and have a thorough understanding of study requirements to maintain standards of excellence in clinical trial management. Management determines the focus of the CRP depending on the requirements of the department upon hiring. Duties and responsibilities may shift between data management and ethics and regulatory affairs as needed – training and coaching will be provided.

Requirements

Health Information Technologist/Health Information Management Diploma or Post-secondary education in a related health care field plus research-related experience.
An acceptable equivalent combination of education and experience may be considered.
Demonstrated ability to work effectively, both independently and as a member of a multidisciplinary team.
Demonstrated ability to prioritize, problem solve multi-task and work under pressure while meeting multiple deadlines.
Excellent communication and interpersonal skills, with the ability to effectively communicate complex information to individuals from diverse backgrounds.
Demonstrated proficiency in Microsoft Office.
Demonstrated attention to detail and accuracy.
Regular exposure to human biologics such as blood, urine, tissue, which have the potential to be classified as an infectious substance affecting humans.
Ability to handle of dangerous goods such as liquid nitrogen and dry ice.
Ability to lift up to 50 lbs (e.g. boxes, binders, samples with dry ice).
Satisfactory employment record.
Legally able to work in Canada.

Nice To Haves

Experience working in oncology and/or blood disorders.
Clinical trials experience.
Ethics and regulatory affairs experience.
Certified in clinical research (e.g. SoCRA or ACRP).
Experience working or volunteering in a health-care environment.
Experience with electronic health records and data entry applications.
Ability to speak French is considered an asset.

Responsibilities

Screening and recruiting eligible participants for active research studies in accordance with protocol guidelines and regulatory requirements.
Explaining the study to participants and answering questions about non-interventional trials in order to obtain informed consent/assent, from patients and families (excluding interventional trials).
Ensuring adherence to the study protocol by interpreting and abstracting health information to enroll eligible participants.
Preparing and shipping biological samples and radiographic images.
Extracting, compiling, submitting, and retaining patient data for the duration of the study.
Monitoring study compliance.
Managing clinical trial patient files.
Communicating effectively with study sponsor representatives and members of the study team.
Preparation, submission, and follow-up of required committee and board approvals necessary for the conduct of clinical research.
Serving as a liaison with appropriate departments and external agencies to ensure the smooth and ongoing operation of the research project.
Maintaining standards of excellence in clinical trial management.