Clinical Trials Coordinator- Clinical Trials- Temporary Full Time

Summary of Position:

The clinical research coordinator (CRC) provides leadership and guidance to the multidisciplinary research team. Responsibilities include overall management of all aspects of clinical trials including timelines and reporting. In this role the CRC also ensures the alignment of the clinical research objectives with the Sault Area Hospital strategic objectives. The CRC works collaboratively with key leaders within the institution to integrate the research resources in their respective departments.

The Clinical Research Coordinator (CRC) ensures the successful implementation, execution and completion of research protocols – from study set-up to closeout. The CRC coordinates and oversees clinical trials to ensure compliance with the study protocol, as well as ethical, regulatory and sponsor requirements, and GCP and standard operating procedures.

Duties:

Conducts a needs assessment for the clinical trial skill sets for each study
Responsible for building relationships with academic and industry partners to support and enhance clinical trials activities
Act as liaison between clinical trial site and sponsor representative
Developing and implementing strategies to measure clinical trials productivity, including identification and measurement of key performance indicators
Facilitate conduct internal auditing and monitoring of clinical research to ensure accurate, complete collection of data including pharmacy documentation to ensure compliance with Good Clinical Practice guidelines
Facilitate external auditing of clinical research by regulatory bodies
Conduct and document informed consent discussion
Prepare clinical trials reports for both internal and external bodies
Prepare and submit applications and regulatory submissions to local research ethics board.
Develop tools or processes to organize and track clinical trial activities
Interact and correspond with investigator, site staff/departments, sponsor, monitors
Coordinate REB submissions and communications and ensure REB approvals are obtained for new protocols and annual IRB renewals
Attend protocol investigator meeting
Coordinate staff training on the protocol prior to study activation
Enroll eligible study subjects (register/randomize)
Monitor subject scheduling and protocol compliance
Ensures subject completion of study forms (QOL, diaries)
Provide patient education
Collect, process, store and ship study samples (ex. pharmacokinetics)
Data collection and source documentation
Complete adverse event and serious adverse event reports
Complete case report forms (CRFs)
Ensure that protocol amendments are appropriately distributed, communicated and approved
Review and update the Standard operating policies and procedures to ensure compliance with the regulatory guidelines
Develop and negotiate study budgets and contracts.
Oversee invoicing and payments for various studies.

Qualifications:

Bachelor degree in a health related field or equivalent an asset
Relevant clinical experience in therapeutic area involved preferred
Clinical Research Coordinator certification (SOCRA, ACRP) an asset

Skills & Ability:

Excellent oral and written communication skills
Communication of empathy, warmth and respect for subjects
Proficiency in drug therapy, drug management, drug accountability
Ability to write order sets for the administration of study drugs
Ability to work within multiple sponsor initiated portals ( SIP, My Trials, etc), Electronic case report form environments (Medidata RAVE, oracle, InForm etc)
Ability to complete mathematical calculations such as medication doses, BSA, BMI, AUC, Gfr etc
Blood processing skill sets
Ability to operate lab equipment
Maintains subject confidentiality

To apply to this exciting opportunity please send a cover letter and resume outlining how your knowledge, experience, and personal attributes are a good fit with the requirements of this position.

All new employees shall be fully vaccinated against COVID 19-prior to their start date. For clarity, fully vaccinated means that 14 days have elapsed after completion of your vaccine series (i.e. full two doses). The Hospital’s Occupational Health team will require evidence of full vaccination prior to an employee’s start date. If not fully vaccinated, the Hospital’s Occupational Health team can assist successful applicants with setting up the necessary appointments to become fully vaccinated, but any start date may be delayed to the date on which a successful applicant becomes fully vaccinated. The hospital’s requirement that successful applicants be fully vaccinated is subject to any accommodation obligations it may have under the Human Rights Code. Employees shall also be required to obtain boosters or other vaccinations related to COVID-19, as deemed necessary by the Hospital, and any failure to do so will be considered willful misconduct and/or disobedience and will result in the termination of the Employee’s employment without notice or pay in lieu thereof.

Sault Area Hospital is a respectful, caring, and inclusive workplace. We are committed to championing accessibility, diversity, equal opportunity and maintaining a barrier-free selection process for job applicants. Requests for accommodation can be made at any stage of the recruitment process providing the applicant has met the requirements for the open position. Applicants need to make their requirements known to the Human Resources department when contacted. All requests are handled confidentially.

This position is covered by a collective agreement. Applications from outside the bargaining unit are welcome, but can only be considered if the position is not filled from within the bargaining unit.