Our FSP team is currently seeking a Sr. CRA 2 with 4 years of monitoring as well as strong Oncology monitoring experience residing in the Toronto Canada area.
WHAT YOU WILL DO
You will utilize your skills knowledge and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities:
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites maintenance of study files conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned -
Responsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
Complete Serious Adverse Event (SAE) reporting process production of repo11s narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
Assist with training of new employees -monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision ifapplicable) and may act as a local client contact as assigned
Perform other duties as assigned by management
Requirements
University or college degree or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
4 years of Clinical Monitoring experience
Oncology experience is required
Ontario Canada location
60-70% overnight travel
The important thing for us is you are comfortable working in an environment that is:
Fast paced: where no deviations from the study protocol are allowed and not meeting a timeline for even few minutes will create a quality issue.
Changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Technology based. We collect our data directly into an electronic environment.
Work Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Frequent travel to clients/ site locations with occasional travel both domestic and international.
Physical Requirements:
Ability to sit for extended periods and operate a vehicle safely.
Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
Occasional crouching stooping with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.
#LI - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here.
Required Experience:
Senior IC
Employment Type : Full-Time
Experience: years
Vacancy: 1
Sr. CRA 2, FSP Oncology Ontario, Canada • Toronto, Ontario, Canada
We are looking for pre‑sales professionals who have a successful track record helping large enterprises become more data‑driven.Working with the Enterprise Account Executive (AE), the Sr.Solutions ... Show more
We are looking for pre-sales professionals who have a successful track record helping large enterprises become more data-driven.Working with the Enterprise Account Executive (AE), the Sr.Solutions ... Show more
Join ParaMed’s compassionate nursing team in Ontario, Nova Scotia, and Alberta.We are hiring qualified RNs, RPNs, and LPNs to provide vital in-home care services.At ParaMed, our mission is to offer... Show more
Join SE Health as an Expert Clinical Leader to innovate patient care.This advanced practice position thrives on developing model care solutions and advancing clinical excellence through collaborati... Show more
Embrace a leadership role in Medical Affairs with Astellas in Toronto, Canada.This position offers a unique blend of strategic direction, team oversight, and innovative medical program development ... Show more
Reporting to the Field Medical Lead, the Medical Science Liaison (MSL) is responsible for establishing and maintaining peer-to-peer relationships with leading physicians, referred to as Key Opinion... Show more
Sales, Clinical Business Manager- Magnetic Resonance Imaging (Eastern Canada- ON/QC/NB/NS).We are looking for a dynamic Clinical Business Manager for our MRI modality, who will serve as the clinica... Show more
A leading healthcare organization in Alberta seeks a Director of Clinic Operations to oversee clinic performance and enhance patient experiences.The ideal candidate will have over 5 years of leader... Show more
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into... Show more
Join Everest Clinical Research as the Associate Director of Biostatistics, where your expertise will shape clinical trial strategies and project management.This role offers a blend of operational l... Show more
Supports FME Canada’s mission, vision, core values and customer service philosophy.Adheres to the FME Canada Compliance Program, including following all regulatory and division/company policy requi... Show more
Medical Director, Canada Plasma Operations Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols ... Show more
In this opportunity as a Sr Research Engineer, you will:.Develop and Deliver: Applying modern software development practices, you will be involved in the entire software development lifecycle, buil... Show more
A global biopharmaceutical company seeks a Medical Science Liaison for a short-term remote position.This role requires a medical or pharmacy degree, focusing on scientific engagement with healthcar... Show more
A leading pharmaceutical firm is seeking a Senior Lead Clinical Data Manager to drive data strategy and lead high-impact clinical projects fully remotely in Canada.The role requires extensive exper... Show more
Clinic Director - Aurora Physiotherapy & Rehabilitation Centre.Location: 14800 Yonge Street, Aurora, ON, L4G 1N3.Are you a visionary Physiotherapist, Occupational Therapist or Chiropractor that is ... Show more
A leading clinical research organization in Toronto seeks an experienced Clinical Research Associate to serve as the primary contact for investigational sites.The ideal candidate will ensure compli... Show more
The MSL will provide scientific information to healthcare professionals and stay current on lung oncology trends. Show more
Shape the future of AI at Huawei Canada as a Senior Principal Researcher, focusing on advanced algorithmic techniques.Lead innovative research that integrates with AI products.Huawei Canada is look... Show more
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into... Show more
