Job Description
Position Title:
Clinical Research Coordinator I (CRCI)
Department:
Clinical Operations
Reports To:
Operations Manager, Assistant Operations Manager
Direct Reports:
N/A
POSITION FUNCTION
The Clinical Research Coordinator I (CRC I) perform 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.
Organization Summary
Our Passionate Cause:
Revolutionizing Research & Changing Lives!
Organization Profile:
Centricity Research is a clinical research organization with more than 40 sites, access to over 1.6 million patients and participants, and more than 150 active investigators across Canada and the southeastern United States. Our name, Centricity Research, was purposefully chosen to signify the fact that we are customer centric. Our study participants, sponsors, CROs, and physicians are the cornerstone of our business. The name Centricity Research also highlights the fact that our organization has earned a position of prominence and importance within the industry. We aim to build and nurture strong, trusting relationships with all audiences, and being customer-centric is embedded within our company culture.
FUNdamentals:
Centricity Research recognizes the following core values as being essential characteristics for individual and collective success:
- Dream Big
- Go Above and Beyond
- Do The Right Thing
- Be Curious
- Have Fun
Essential Functions
Protocol and Safety:
- Ensure the safety and welfare of study participants
- Conduct the study as per protocol, GCP, and 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, 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
Preferred:
- Experience working in a health care environment e.g. blood pressure sphygmometers, automated blood pressure machines, weight scales, and ECG machines
- Knowledge of medical terminology
- Phlebotomy experience an asset
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 may require overnight/weekend hours
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
The above statements are intended to describe the general nature and level of work being performed by most people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and requirements. Scheduling flexibility is required to accommodate changing business needs.
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