Clinical Research Coordinator Ii

**Position Overview**:
The Clinical Research Coordinator II (CRC II) at the Prostate Cancer Centre plays a crucial role in our research team, performing vital administrative tasks.

This position involves close collaboration with study investigators and urologists at the Southern Alberta Institute of Urology (SAIU), pharmaceutical representatives, and research participants. The CRC II is responsible for conducting study protocols in accordance with Good Clinical Practices (GCP) and the site’s standard operating procedures.

The CRC II will manage multiple studies of varying intensity and complexity. This role requires a moderate level of independence, although guidance will be provided by peers and the manager. The ability to multitask and work autonomously is essential for success in this role.

This is a full-time position (40 hours per week). PCC offers a competitive salary (salary range $57,000-$62,000) and a comprehensive benefits package.

**Responsibilities**:
**Clinical Research Coordinator (90%)**:
**1. Study Management and Supervision**:

- The level of role will be expected to perform study visits with moderate to mínimal supervision or additional direction required.
- Expected to resolve issues with moderate to mínimal supervision and implement corrective actions and preventative actions (CAPA).
- Make recommendations to manager after discussing with peers and manager, with full responsibility for outcomes.
- Provides guidance to less experienced staff

**2. Clinical Research Conduct**:

- Conduct clinical research studies (including pharmaceutical sponsored and investigator initiated) according to the study protocol, GCP, and the PCC Research standard operating procedures (SOPs).
- Develops and implements the clinical trial recruitment and retention plan for each study.
- Recruits and enrolls participants into the clinical trials in accordance with protocol inclusion/exclusion criteria.
- Conduct the informed consent process with study participants.

**3. Data Management**:

- Schedule study participant visits.
- Collect and enter data into the study case report forms.
- Coordinates data flow internally and externally. Collects data from all sources (electronic and paper) including but not limited to electronic health records, other databases and paper medical records/charts.
- Assists in the creation of data reports for quality assurance purposes.
- Participates in internal and external audit procedures.
- Complete all study visit documentation including physician follow-up letters.
- Create source documents.
- Report on study metrics and KPI’s.

**4. Study Documentation and Compliance**:

- Maintain the study general correspondence binder.
- Maintain the study specific Staff Delegation Log / Training Documents.
- Coordinates and facilitates monitoring and auditing visits
- Actively participate in the Sponsor’s site visits.
- Resolve all monitoring findings in a timely manner.
- Document and report all adverse events to the Investigator and Sponsor.

**5. Study Supplies and Sample Management**:

- Obtain, process, and ship biological samples.
- Receive and acknowledge study supplies; perform drug accountability.
- Monitor and order study supplies.

**6. Regulatory and Ethics Compliance**:

- Maintenance of regulatory documents.
- Ethics submissions.
- Study start-up activities
- Conduct study participant visits and establishes a strong, positive and supportive relationship with each participant, fostering compliance to protocol requirements and trust. Acknowledges the importance of each participant’s role as research volunteer.
- Ensures that the rights, safety and welfare of all participants are respected and protected as per applicable ethical requirements and regulations.

**Other Responsibilities (10%)**:

- Participate in research and PCC staff meetings
- Annually attend a RAC 2 information session
- Participate in team building and fundraising events as available
- Develop and maintain relationships with volunteers

**Occupational Health and Safety**:

- Protecting their own and others’ health and safety at or in the vicinity of the work site
- Co-operating with their employer or supervisor by following health and safety rules for the job
- Using all hazard controls and wearing personal protective equipment designated or provided by the employer
- Refraining from causing or participating in harassment and violence
- Reporting health and safety concerns and conditions to their employer or supervisor
- Co-operating with any person exercising a duty under the occupational health and safety legislation
- Complying with the occupational health and safety legislation

**Qualifications**:
**Education/ Training**:

- Health-related education (bachelor’s degree in health research, healthcare or clinical research discipline.) A combination of education and experience will be considered.
- Current Good Clinical Practice certification
- Phlebotomy education or skills are an asset

**Ex