Clinical Research Coordinator I

POSITION FUNCTION

The Clinical Research Coordinator I (CRC I) performs a variety of administrative and clinical activities to assist the Investigators in conducting clinical studies.  The CRC I will have a strong understanding of study protocols and will coordinate and manage study activities completely and accurately.

ESSENTIAL FUNCTIONS

Protocol and Safety:

• Ensure the safety and welfare of study participants
• Conduct the study as per protocol, GCP, and WPs/SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals
• Be knowledgeable of study protocol to ensure all study activities are completed correctly

Recruiting, Screening, and Enrolling Study Participants:

• Promote and support study participant recruitment and enrollment initiatives
• Ensure proper written informed consent from each study participant prior to participation in the study and maintained during the study

Study Visit Completion:

• Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator
• Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site
• Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site
• Obtain all necessary documentation as required by the protocol
• Timely and accurate completion of source, data, CRFs, queries and CTMS

Safety Reporting & Data Integrity:

• Collect and report all adverse events and abnormal results to the Investigator, Sponsor, and REB as per protocol and REB requirements
• Report Serious Adverse Events and other expedited safety events within 24 hours to the Investigator, Sponsor, and REB and complete appropriate follow-up as required
• Accurately dispense investigational product and other study supplies
• Document receipt, storage, and maintain inventory of investigational product and other study supplies
• Coordinate and prepare for monitoring visits and audits
• Perform regular self and peer quality control (QC) checks and other QC tasks as deemed necessary
• Review source documents and any other research documents required for the successful conduct of the clinical research study
• Maintain and update all required documentation in the Investigator Site File, as required
• Complete periodic/annual study reports for REB, as required

General:

• Abide by GCP, WPs/SOPs, company guidelines, and local healthcare privacy regulations
• Communicate study questions to the Investigators/Research Management/other CRPs
• Communicate study updates and learnings with applicable staff
• Maintain professional relationships with study participants, physicians, industry representatives and vendors of trial management
• Support and maintain lab supplies, documents, equipment, as required
• Provide input on quarterly recruitment targets and support efforts to achieve site/company targets
• Attend site, company, and sponsor meetings and study trainings
• Participate in on-call schedule, if required
• Timely phone and email communication
• Organize and participate in community and company outreach events as required (expectation 1-2 per calendar year)
• Archive study and study documents upon completion of a study
• Assist the Research Management and Investigators with any other research tasks as required

EDUCATION/EXPERIENCE

Minimum:

• CAN: College/University degree in a relevant field of science

• US: HS/GED
• CAN/US: Depending on role requirements, specific degree and licensure from designated provincial/state body the location of the clinical site (ex. RN, MLT, etc.)
• Active BLS certification (for CPU setting)
• Proficient IV and phlebotomy skills (as applicable to the site requirements)

Preferred:

• Experience working in a healthcare environment   e.g. blood pressure sphygmometers, automated blood pressure machines, weight scales, and ECG machines
• Knowledge of medical terminology
• Phlebotomy experience an asset
• Active ACLS certification (for CPU setting)

CORE COMPETENCIES/SKILLS

Prerequisite (Essential):

• Excellent communication skills (verbal and written)
• Excellent computer skills (MS Word, Excel and Outlook)
• Attention to detail
• Ability to manage time efficiently
• Self-directed
• Teamwork & Collaboration
• Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
• Flexible & Adaptable
• Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Foundation:

• Conflict resolution
• Receptive to feedback
• Empowering & Developing others
• Empathy Skills
• Planning and organizing skills
• Excellent problem-solving skills
• Achievement oriented
• Analytical ability
• Initiative
• Decision making

Leadership:

• Forward thinking
• Innovative
• Creative 
• Strategic thinking
• Self confidence
• Strong interpersonal skills

PHYSICAL DEMANDS

• Physical demands include but not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
• Frequently required to complete work on the computer in a seated position
• May be required to lift light boxes (10 - 20lbs)

WORKING CONDITIONS

• Modern medical office environment or home office environment
• Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations
• Required to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations
• Some positions and locations may require work to be done outside of regular business hours (which may include overnights, weekends, & holidays) [CLBHC1] 

BENEFITS

• Opportunities to work with internationally renowned physicians
• Comprehensive health benefits, competitive salary
• RRSP or 401(k) contribution matching
• Continued opportunities for growth & development; yearly education allowance   
• Paid holiday closures and employee appreciation days off