Research Coordinator

**Job Title**: Research Coordinator - Clinical Trials

**Reports to**:Research Manager

**Position Summary**:
The Research Coordinator will be responsible for the administration of clinical trials and/or prospective research studies. The scope of duties includes study initiation activities including obtaining ethical and institutional approvals, study budget and contractual review, as well as study implementation activities including recruiting, obtaining informed consent, monitoring, conducting study visits, data collection, and following up with participants with chronic disease who are part of various clinical research studies. The research coordinator will also administer questionnaires and conduct chart reviews in accordance with the research ethics board approved protocol, ICH-GCP, and TCPS2: CORE. They will navigate and maintain on-going submissions including amendments and annual approval as required.

The Research Coordinator will also help to liaise with clinical trial sponsors and will provide data-informed decisions for program enhancement, and will lead the development (i.e., writing), organization and implementation of various research protocols. Other duties as assigned. The incumbent will provide updates on study progress to the Research Manager, Principal Investigator, and Project Manager on a weekly basis.

**Qualifications and Competencies**:
**Education**:

- Completed graduate degree (MSc or higher) in a related discipline.
- Minimum 5 years clinical research experience

**Experience**:

- 5+ years of clinical research experience in Health Canada or FDA regulated trials is required, including obtaining informed consent, participant recruitment, patient visits, data collection and data management activities.
- Previous experience working with industry-sponsored as well as investigator initiated clinical trials is required.
- Previous experience working with patients with chronic kidney disease is a strong asset.
- Previous experience conducting research in a clinical setting is considered a strong asset.
- Proficient in Microsoft Office programs including Microsoft, Excel, Power Point, and Word.
- Completion of ICH-GCP, TCSP2-CORE, and PHIA training is required.

**Skills and Abilities**:

- Strong interpersonal skills and ability to work within a team-oriented environment
- Effective oral and written communication skills
- Must be able to work independently and with limited supervision.
- Excellent organization and time management skills. Ability to follow oral and written instructions.

**Contacts and Relationships**:

- Ability to establish and maintain collaborative working relationships with various levels of front-line clinical staff and research staff, including management.
- Expertise in liaising with industry partners and funders, Clinical Research Organizations (CROs), clients and partner organizations for study initiation and implementation.

**Duties and Responsibilities**:

- Leads the implementation of various protocols from inception to completion, which may include protocol writing and development, protocol implementation and assists in making recommendations for program improvement.
- Recruitment of participants into research studies including obtaining informed consent, coordinating research appointments and visits to study site laboratories, and conducting study assessments. Study assessments may include the administration of questionnaires, physical and cognitive function tests, as well as other project specific exams, as required.
- Study data management, including collecting and recording clinical data from patients or medical records, entering data into a study database and performing periodic audits of data accuracy as stipulated in the protocol or manual, assuring proper storage of study documents (electronic or otherwise) to protect participant confidentiality and privacy.
- Project management of single-site and multi-site research studies including reviewing and developing budgets and contracts, protocol updates and modifications, planning project resources, developing standard operating procedures and training materials, coordination of patient remuneration and focus groups, overseeing study set-up and protocol implementation, and tracking study-related payments.
- Attendance at weekly team meetings and communication with senior management, project leads, partner organizations and front-line clinical staff.
- Helps to identify and manage strategic partnerships and research collaborations with policy makers, health administrators, academics and industry.
- Prepares, edits and reviews and submits reports, manuscripts and presentations
- Communicates regularly with the Research Manager Principal Investigator, and/or Project Manager on assigned projects.
- Assists with the training of junior staff members and project team members.
- Assisting with inspections and audits related to research studies (e.g. Health Canada inspections)
- Other duties as assigned.

Pay: