Research Assistant

The Patient Engagement Coordinator is responsible for all research related recruitment initiatives in order to recruit high quality patients in accordance with Centricity Research recruitment guidelines. The Patient Engagement Coordinator will demonstrate knowledge of protocols including inclusion/exclusion criteria and be familiar with the medications and medical diseases that coincide with research conducted at Centricity Research. The Research Assistant (RA) performs a variety of administrative and clinical activities to assist the Investigators and CRCs in conducting clinical studies. The RA will support study activities completely and accurately.

**_ 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**:

- Support study participant recruitment and enrollment initiatives (as designated by RM)
- Work on enrollment and retention initiatives with Recruitment Team Lead
- Problem solve and create contingency plans to optimize enrollment via recruitment initiatives
- Obtain and maintain computerized database of all ad callers
- Accurately complete recruitment tracking log and all applicable clinical trial management systems
- Assist the Patient Engagement Lead, Research Operations and/or Investigators with any other tasks as required
- 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
- 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** PHYSICAL DEMANDS**
- Physical demands include but not limited to prolonged sitting, light lifting