Clinical Research Coordinator

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
- 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