Clinical Trials Coordinator

Clinical Trials / Essais clinique Brampton, ON


Description

Poste chez Dynacare

Job Posting: Clinical Trials Coordinator 
 
Where YOU work, makes a difference. 
Life is precious and every moment matters. Dynacare is helping Canadians achieve a healthy future with care and wellness solutions that are convenient, understandable, and accessible. When you join our team, every day is an opportunity to get better and be inspired. It’s an environment where you can grow your career in any direction you choose. We’re evolving our technology and optimizing our processes, so you can do your best work, make a meaningful impact, and thrive.
 
Are YOU our next Clinical Trials Coordinator? 
We’re looking for a Clinical Trials Coordinator to join our Clinical Trails team in Brampton, Ontario. You will be responsible for training and customer service activities for assigned investigators and is responsible for client satisfaction for assigned studies. You will be responsible for establishing effective working relationships with staff, investigators and Contract Research Organization (CRO) clients.  
 
This is a permanent, full-time position working in a day shift. 
 
Internal job posting closes at 5:00pm(EST) on June 19, 2024.  
 
Why Dynacare is an amazing place for YOU: 
  • Join an award-winning "Top Employer" with meaningful and impactful career opportunities
  • Access a health and wellness benefits program that supports you and your loved ones
  • Grow and thrive with a dynamic, successful company through internal mobility opportunities
  • Invest in your future through RRSP match benefits and an employee stock purchase program 
  • Experience a collaborative, diverse workforce that prioritizes dignity and respect for all
  
How YOU will make a difference: 
  • Provide training sessions to assigned investigators for study-specific logistics and laboratory procedures for assigned studies.
  • Resolve data clarification issues, internal review of information, contact with investigator for resolution, follow- up with investigator for information, correction of information in AS400 and re-issue of lab reports to all parties.
  • Require contact and negotiation with staff from other departments, client investigators and CRO clients to obtain and give explanations or information (technical or other) to ensure information is understood
  • Represent Dynacare to clients in a relationship in which the Project Coordinator must deal with requests, complaints and/or issues with a tactful approach yet establish an atmosphere of trust
  • Expected to be able to use negotiation skills to resolve issues with clients without the need for elevation
  • Proactively evaluate potential problems on the job and initiate action to limit negative outcomes
  • Receive and disseminate study-related regulatory documents, reports and Study-specific correspondence
  • Perform Quality Assessments of documents for completeness and compliance with protocol and appropriate regulations
  • Assist in investigating incomplete, inaccurate or missing documents to ensure accuracy and completeness of data
  • Responsible for documentation of data discrepancies, negotiation of resolution of discrepancies with investigators or CRO clients and revision of client data
  • Maintain files for each sponsor, study, subject and/or investigator
  • Manual fax reporting and mailing of all lab reports to all parties
  • Perform study-specific training sessions for study investigators
  • Coordinate with investigators to ensure accurate investigator contact information and specific investigator requirements to implement the laboratory portion of the Clinical Trial
  • Prepare multiple study-specific investigator documentation
  • Coordinate initial shipments of supplies to study investigators
  • Monitor continually for full compliance for test completion and reporting times. If not completed, search and negotiate on daily basis within Specimen processing and/or Clinical Departments to locate missing specimens and forward to appropriate area
  • Verify worksheets for outstanding results on a daily basis
  • Review all lab reports for confirmation of accuracy of data entry from original requisition
  • Coordinate and negotiate improved performance with relevant departments if Dynacare is not compliant with its own or client-requested expectations
  • Manual data cleansing to ensure that all data discrepancies in AS400 for specific Clinical Trials are rectified and revised on a regular basis
  • Use Imaging system to seek information for clarification of information
  • Coordinate with Logistics Coordinator to track shipments for prompt delivery and problem solve as required
  • Monitor kit supplies for expiration and re-supply requirements
  • Coordinate kit preparation to ensure kits are prepared and re-supplied immediately
  • Process, data enter, manage and coordinate frozen PK specimens and documentation requirements for shipments both to Dynacare and to sub-contract laboratories
  • Manually manage client-specific databases and critical information for complete and 100% accurate patient
  • and specimen information for submission to Dynacare clients for submission to FDA
  • Perform routine equipment maintenance and daily monitoring of Clinical Trials freezers
  • Perform document maintenance including minor troubleshooting following manufacturer’s instructions
  • Assist in reviewing existing Standard Operating Procedures and provide input on possible process improvements
  • Ensure to work in compliance with FDA regulations, Good Clinical Practices (GCP) and general Good Laboratory Practices (GLP)
  • Responsible to follow all relevant pre and/or post analytical QA protocols as described in the company QA manual
  • Perform duties in accordance with established company policies and procedures
  • Contribute towards Dynacare’s learning and knowledge-based culture by sharing in the responsibility of training and skill development of new team members as requested
  • Responsible to foster a commitment to quality and customer service within their areas of responsibility
  • Establish trusting working relationships with External Customers (investigators and CRO clients) for every client study  
  
What YOU bring to the role:   
  • Science-related or medical laboratory certification or equivalent
  • 2 to 3 years of related experience required
  • Ability to perform under pressure, manage multiple projects and respond to changing priorities and deadlines in a fast-paced environment
  • Strong problem solving skills
  • Social Process Skills  
 
Working conditions: 
  • Normal office and medical laboratory environment
  • Exposure to Bio-hazardous Infectious Substances, Dry Ice hazards and temperature differences
  • Exposure to kit manufacturing hazards - multiple boxes, cardboard, supplies, lifting and dust
  • Multiple simultaneous demands
  • Eyestrain from extensive manual review of databases for missing or data discrepancies
  • Fine motor keyboarding and repetitive movements
  
Passionate about supporting healthy lives with commitment and care? Please apply today and let us open the door to your extended career journey.   
 
Dynacare has been a “Top Employer” for many years and there is a reason why. We are a great place to work. At Dynacare, we’re proud to hire the best people. If you are looking for a meaningful career where you can support healthy lives with commitment and care – we would like to meet you. We hope you will join us in our journey to become Canada’s health and wellness solutions leader.     
 
Dynacare is proud to be an equal opportunity employer committed to the attraction, selection, advancement, and fair treatment of all individuals. We believe that our diversity is our strength, so we employ a diverse workforce and respect the needs of all our employees.
 
In accordance with provincial legislation and our Accommodation Policy a request for accommodation will be accepted as part of the Dynacare hiring process.