Research Assistant

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
 

As a Research Assistant, you will perform a variety of administrative and clinical activities to assist the Investigators and CRCs in conducting clinical studies.  The RA will have a strong understanding of study protocols and will support 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 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:
 

• Support study participant recruitment and enrollment initiatives (as designated by RM)
• 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 for ongoing visits (screening & randomization visits as designated by RM)
• 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
• Perform regular self and peer quality control (QC) checks and other QC tasks as deemed necessary
• Support CRPs in Investigator Site File maintenance and updating, as required
  
   

General:
 

• Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
• Communicate study questions to the Investigators/Research Management/other CRPs
• Maintain professional relationships with study participants, physicians, industry representatives and vendors of trial management
• Attend site, company, and sponsor meetings and study trainings
• Participate in on-call schedule, if required by the site
• Timely phone, TEAMS and email communication
• Organize and participate in community and company outreach events as required (expectation 1-2 per calendar year)
• Assist with remote and in-person monitoring visits
• Support CRPs in addressing monitor findings, and follow-up
• Assist the clinical team with paper and electronic filing and archiving
• Gather, enter, and/or update data to maintain company records and databases as directed
• Perform specified tasks of Lab Specialist (based on qualification and designation), if required by the site
• Assist the clinical team with scheduling and coordinating appointments, reminding study participants of their appointments, and checking study participants in and out of their visits
• Perform role of un-blinded research staff (e.g. Investigational Product dispensation and/or QC), if required by site and protocol
• Maintain adequate stock of clinical instruments and supplies in exam rooms and lab area, if required by the site
• Assist in ordering trial and non-trial medications, if required by the site
• Assist in organizing patient waiting areas, exam rooms, laboratories, medication areas, and storage areas, if required by the site
• Manage front desk supervision at sites that require this support and serve as backup to Administrative Assistant (in Sites with this position)
• Assist Research Management and Investigators with any other research tasks as required

Qualifications