Clinical Research Coordinator I

Centricity Research; Columbus (OH); On-site; USD 45,000 - 65,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Research Coordinator I to support study management and participant safety in clinical trials. The role involves coordinating study activities, ensuring compliance, and performing required clinical tasks. Ideal candidates will possess a relevant degree and BLS certification with excellent communication and teamwork skills. Opportunities for career growth and development are offered.

Benefits

Comprehensive health benefits

Competitive salary

401(k) contribution matching

Yearly education allowance

Paid holiday closures

Qualifications

• College/University degree in a relevant field of science or HS/GED.
• Active BLS certification (for CPU setting).
• Proficient IV and phlebotomy skills as applicable.

Responsibilities

• Ensure safety and welfare of study participants.
• Conduct studies as per protocol and regulations.
• Perform vital sign assessments and administrative tasks.

Skills

Communication skills

Attention to detail

Time management

Teamwork & Collaboration

Education

College/University degree in a relevant field of science (CAN) or HS/GED (US)

Active BLS certification

Tools

MS Word

Excel

Outlook

Job description

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
  
  

[CLBHC1]Apply to JD template for all roles - thinking lab, study admin, RA, SI, etc. Many roles that could be asked to support. [CLBHC1]