Clinical Research Coordinator I

Description

Centricity Research believes that everyone deserves an opportunity to help advance medicine - for themselves and for those they love. We are committed to connecting real-world opportunities in clinical research studies with people across the globe.

 

• We educate and empower our patients who are partners in this work.

• We are building the world's most passionate and skilled team of clinical researchers, and administrative team members, who are valued and supported over an entire career.

• We create value for our sponsors worldwide by providing great service and timely, accurate results.

What makes us different?

Unlike our competitors, we are building a true platform, enabling team members, patients and partners to have the highest quality and consistent experience.  We are effective across a broad range of therapeutic areas including Phase 1, oncology, and gene trials.  We are intentional about our growth - choosing to grow where it benefits our patient diversity, capabilities, and research experience.  

 

Our mission? To connect people with the future of medicine through groundbreaking research, all while keeping the human experience at the heart of what we do.

 

How We Work

We are passionate about the work we do and strive to incorporate our Core Values in all we do. Our Core Values are:

• Quality

• Care

• Be the Change You Seek

• One Team

• Grow for Good

• Own It

Position Summary

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:

• US: HS/GED

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)
• Active BLS certification (for CPU setting)
• Proficient IV and phlebotomy skills (as applicable to the site requirements)

Benefits

• Comprehensive health benefits

• 401(k) with company match

• Continued opportunities for growth & development; yearly education allowance

• Flexible PTO

• Opportunities to work with internationally renowned physicians
   

Ready to be part of something bigger than yourself? We are excited to review your resume and cover letter explaining why you would be a good fit for our unique and fun team.

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. 

Qualifications