Job title: Clinical Research Coordinator-Trial Launch Team
Company: Alberta Health Services
Job description: Your Opportunity:
Are you an experienced clinical trial professional? If so, you may be the person we’re looking for. The Clinical Trials Coordinator coordinates & assists with study activities within various areas of the Unit. This position will be assigned to our Trial Launch Team (TLT) primarily but may assist other tumor groups as required. They report to the CTU Manager and are responsible for facilitating clinical trial processes and completing delegated study tasks. Responsibilities include: Preparing REB application submissions, amendments and progress reports. Draft, negotiate and finalize Informed Consent Forms, liaising with Industry partners on ICF content and ethics submission timelines. Develop and maintain strong relationship(s) with PI’s, hospital personnel and representatives from outside agencies regarding ongoing conduct of clinical research. Complete and maintain regulatory forms and critical documents. Develop a system to organize, plan and track workflow related to clinical trial activities to ensure timely documentation and data submissions. Other duties may include abstracting data to complete study forms, flow sheets, or CRF’s as required by protocol. Review source documents and case report forms with site teams/study representatives and resolve data queries. Prepare, report and maintain various study metrics. Coordinate monitoring visits, and assist with site audits, and regulatory inspections. Registering patients, inform appropriate personnel of assigned study treatment, notify team of communications regarding adverse drug reaction reports, and ensuring safety documentation is completed.
As a Clinical Research Coordinator, you will provide support for research studies through the identification, collection, and reporting of clinical trial data. You will compile research, reports and regulatory documents as required by the protocol, and study/sponsor. This involves ensuring research information is timely, accurate, valid, meaningful, and to the sponsor’s satisfaction, and that studies are run according to local and global regulations.
- Classification: Clinical Resrch Coord (ACB)
- Union: HSAA Facility PROF/TECH
- Unit and Program: Clinical Trials Unit, Cancer Care
- Primary Location: Cross Cancer Institute
- Location Details: As Per Location
- Multi-Site: Not Applicable
- FTE: 1.00
- Posting End Date: 16-NOV-2023
- Temporary Employee Class: Temp F/T Benefits
- Date Available: 11-DEC-2023
- Temporary End Date: 11-DEC-2024
- Hours per Shift: 7.75
- Length of Shift in weeks: 2
- Shifts per cycle: 10
- Shift Pattern: Days
- Days Off: Saturday/Sunday
- Minimum Salary: $32.34
- Maximum Salary: $41.21
- Vehicle Requirement: Not Applicable
Completion of a minimum two year diploma or certificate in a health care related field. Minimum of two years’ clinical research experience. Additional Required Qualifications:
Experience within a Clinical Trials or Research Ethics role and work environment. Must be familiar with Trial Launch, Ethics or study initiation (start up) activities. Knowledge and regular usage of ethics submission systems (IRISS, REMO). Prior experience working with pharmaceutical sponsors and CRO’s. Strong negotiation, multitasking and communication skills. Adaptable and able to coordinate and manage numerous simultaneous projects to meet strict deadlines. Knowledge of oncology medical terminology, anatomy and tumor staging. ICH-GCP training and familiarity with clinical trial regulatory reporting requirements. Excellent computer skills and experience working with Microsoft Office programs. Able to work well within a team environment, but able to complete individual assigned projects or tasks according to strict deadlines. Must be able to transport large volumes of materials (study supplies, charts, boxes, etc.) to various areas regularly and push/pull loaded carts. Physical demands of the job include sitting for extended periods, lifting office/medical supplies and equipment weighing up to 30 lbs., and using repetitive motions, lifting, bending, reaching and standing for prolonged periods. NOTE: To ensure your skills and qualifications are considered, please attach a resume and cover letter with your application. Preferred Qualifications:
Preference given to those with a bachelor’s level degree (health-related). Completion of an approved Clinical Research or Data Management Certificate Program. SoCRA or ACRP certification/membership. Familiar with using and creating spreadsheets, and various databases (e.g. InForm, RAVE) or electronic medical records (e.g. Netcare, ConnectCare, ARIA).
All postings close at 23:59 MT of the posting end date indicated.
A satisfactory criminal record check and/or Vulnerable Sector Search is required prior to your first day of work. Additionally, all employees have an ongoing duty to disclose any charges or convictions that may occur during their employment with AHS.
Healthy Albertans. Healthy
We’re passionate about what we do. Our team of skilled and dedicated health care professionals, support staff, and physicians promote wellness and provide health care every day, all across Alberta.
Everything we do at AHS reflects a patient and family centred approach; it’s about putting patients’ and families’ experiences, priorities and trust first.
We are an equal opportunity employer. AHS values the diversity of the people and communities we serve and is committed to attracting, engaging and developing a diverse and inclusive workforce.
Location: Edmonton, AB
Job date: Thu, 09 Nov 2023 07:51:46 GMT