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Reference Number: 000000892
Posted Date: 3/13/2017
Closing Date: 3/27/2017

Department: The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease
Position: Clinical Research Coordinator II

POSITION TITLE Clinical Research Coordinator II
DEPARTMENT The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease
EMPLOYMENT TYPE Regular Full Time
HOURS OF WORK 37.5 Hours per week
EMPLOYEE GROUP Non-Union
REPORTS TO Principal Investigator

ORGANIZATION DESCRIPTION:

The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease (RMCAD) integrates clinical patient care with innovative, genetics-based research for rheumatic and autoimmune diseases. The centre provides a variety of specialized clinics serving more than 15,000 patients annually. Patients receive treatment for any of the 115 forms of arthritis, including the most serious, potentially life-threatening forms of rheumatic and autoimmune diseases. The Centre has established programs specializing in the care of early arthritis scleroderma, and vasculitis to the benefit of patients in Toronto and across Canada.  For more information about our centre please visit our website at http://www.mountsinai.on.ca/care/rmcad/about-rmcad#sthash.LeNFXyoJ.dpuf.

POSITION OVERVIEW: 

The Clinical Research Coordinator II is a vital member of a multidisciplinary team and will be responsible for leading and organizing various clinical and/ or research projects.  The incumbent will continuously coordinate the flow of work for one main project or multiple projects and will act as a source of information for research activities on a regular basis.  He or she will be responsible for designing or creating new procedures/ technical methods based on experimental objectives and/ or results and the modification of existing procedures.  Exceptional theoretical insight is required to interpret empirical data and extract pertinent information from technical literature. 

JOB RESPONSIBILITIES:

  • Participates in Investigator and initiation meetings;
  • Collaborates with medical doctors and multidisciplinary health care team in the recruitment of study participants (e.g. identifies and screens potential subjects, obtains informed consent, conducts pre-testing and administer questionnaires, or other data collection tools);
  • Plans, implements and coordinates all aspects of data collection and source documentation as per UHN policy and ICH/GCP guidelines;
  •  Identifies problems using assessment skills and report any abnormalities to MD or  appropriate health care team member;
  • Executes study-related administrative tasks, such as the collection of regulatory documents, ethics submissions, study closure, record storage, etc.;
  •  Conducts telephone and/or clinical recruitment interviews to collect data using established criteria;
  • Coordinates and schedules patient visits as per study protocol;
  • Executes all aspects of study visit, e.g. assess adverse events, SAE’s, monitor the patient’s safety and medication, review questionnaires, address data inquiries, perform sample collection, including venipuncture, as well as process and ship samples according to clinical protocol;
  • Ensures adequate storage and is accountable for investigational products, including product administration;
  • May contribute towards the development of guidelines, procedures and standards i.e. Source document templates
  • Establishes and orders adequate supplies per protocol;
  • Assesses study-related literature;
  • Liaises with sponsor for monitoring and audits;
  • Provides leadership, guidance and preceptorship to new staff;
  • Participates in departmental, institutional or international seminars;
  •  Identifies and resolves employee relation issues;
  • May participate and/or make recommendations for the recruitment, orientation, promotion, disciplining, and/or termination of staff as required;
  • May provide direct supervision of assigned personnel for one or more studies/assignments
  • Demonstrates willingness to learn; and
  • Interacts with both internal and external contacts primarily for the purpose of exchanging and/or clarifying information, and resolving problems within scope of authority

EDUCATION & EXPERIENCE REQUIREMENTS:

  •  Bachelor’s degree in health field or equivalent;
  •  Completion of BCLS Certificate;
  • Completion of or working towards a recognized clinical research certificate (e.g. ACRP);
  • 3-5 years of professional clinical experience, with 1-3 years of experience specifically in clinical research;
  • Demonstrated ability to apply fundamental knowledge of research principles, theories, and concepts;
  • Strong understanding of and ability to apply regulations and guidelines, such as ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPP, as applicable;
  • Strong understanding of IATA shipping regulations and basic laboratory procedures;
  • Must be able to exercises considerable independent judgment and decision making, using  broadly defined policies, practices and procedures, to resolve problems, and seek advice and/or approval for resolution of more complex problems;
  • Exceptional ability to design, develop and maintain tools to facilitate and enhance performance of research tasks and overall work results and conformity to project objectives;
  • Must be able to work under the general direction of investigator and/or more senior coordinator;
  •  Sound ability to identify instructional needs and seeks appropriate resources; Must be able to work well with others within a multidisciplinary team; and
  • Must possess exceptional written and verbal communications skills

Posting open until March 27, 2017. We thank all candidates for applying. Only those selected for an interview will be contacted.

In accordance with Institute’s policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases.

The Lunenfeld-Tanenbaum Research Institute is a scent sensitive environment and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute’s accessibility plan, accommodation and disability management policies and procedures. Should you require accommodation at any point during the recruitment process, including accessible job postings, please contact the Lunenfeld-Tanenbaum Human Resources Department.

Contact Name: Hiring Manager

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