Employment Type: Temporary, Full-time (12-18 months)

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
Continued opportunities for growth & development;
Paid holiday closures and employee appreciation days off

Centricity Research is an equal opportunity employer. We are committed to inclusive, barrier-free recruitment and selection processes and work environments. If you are contacted for a job opportunity, please let us know of any accommodations needed to ensure you have access to a fair and equitable process. Any information received relating to accommodation will be kept confidential.

Centricity Research does not currently utilize Artificial Intelligence for screening or recruitment purposes.

We thank all candidates for their applications, however, only those candidates selected for an interview will be contacted

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Clinical Research Coordinator I