Research Assistant/Patient Engagement Coordinator

Aventiv Research, IACT Health, LMC Manna Research, and True North Clinical Research have united to become the largest network of fully-owned and integrated clinical research sites in North America, Centricity Research. Centricity Research is committed to revolutionize research by creating outstanding clinical trial experiences to improve the health of the community today and tomorrow through clinical research.

Currently, our rapidly expanding team and site network is looking for a Research Assistant/Patient Engagement Coordinator who can work for us on a full-time, hybrid basis, supporting us in Oshawa, Canada.

POSITION FUNCTION

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 have a strong understanding of study protocols and will support study activities completely and accurately.

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.

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:

• Be Curious
• Go Above and Beyond
• Dream Big
• Have Fun
• Do The Right Thing

Essential Functions

Protocol and Safety:

• Ensure the safety and welfare of study participants
• Be knowledgeable of study protocol to ensure all study activities are completed correctly
• Conduct the study as per protocol, GCP, and SOPs

Recruiting, Screening, and Enrolling Study Participants:

• Provide study metrics on a regular basis and provide ongoing feedback regarding outcome of recruitment initiatives
• Obtain and maintain computerized database of all ad callers
• Occasionally attend community lectures, health fairs or events to promote Centricity Research
• Complete database query reviews for study candidacy and conduct outbound calls for study interest
• Return all phone calls/email responses to interested patients within 24 - 48 hours
• Assist the Patient Engagement Lead, Research Operations and/or Investigators with any other tasks as required
• Accurately complete recruitment tracking log and all applicable clinical trial management systems
• Work on enrollment and retention initiatives with Recruitment Team Lead
• Promote clinical trials in the community through outreach events
• Identify appropriate study candidacy based on knowledge of sites’ recruiting and upcoming studies
• Problem solve and create contingency plans to optimize enrollment via recruitment initiatives

Study Visit Completion:

• Timely and accurate completion of source, data, CRFs, queries and CTMS
• Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator for ongoing visits
• Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site
• Obtain all necessary documentation as required by the protocol
• Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site

Safety Reporting & Data Integrity:

• Document receipt, storage, and maintain inventory of investigational product and other study supplies
• 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
• Collect and report all adverse events and abnormal results to the Investigator, Sponsor, and REB as per protocol and REB requirements
• Perform regular self and peer quality control (QC) checks and other QC tasks as deemed necessary
• Accurately dispense investigational product and other study supplies
• Support CRPs in Investigator Site File maintenance and updating, as required

General:

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

Education/Experience

Minimum:

• Canada: College/University Degree OR a healthcare / clinical research diploma (or equivalent experience in a healthcare / clinical research setting (dependent on site requirements for the role)
• US: HS/GED/ Certified Medical Assistant or other medical training

Preferred:

• Clinical Research Certificate is preferred
• Phlebotomy experience is preferred
• Experience in marketing, sales or call center experience

Core Competencies/Skills

Prerequisite (Essential):

• Self-directed
• Excellent communication skills (verbal and written)
• Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines
• Attention to detail
• Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
• Ability to manage time efficiently
• Flexible & Adaptable
• Teamwork & Collaboration
• Excellent computer skills (MS Word, Excel and Outlook)

Foundation:

• Excellent problem-solving skills
• Receptive to feedback
• Empowering & Developing others
• Conflict resolution
• Initiative
• Analytical ability
• Achievement oriented
• Decision making
• Empathy Skills
• Planning and organizing skills

Leadership:

• Creative
• Innovative
• Self confidence
• Strong interpersonal skills
• Strategic thinking
• Forward thinking

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

• Some positions may require overnight/weekend hours
• Required to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations
• Modern medical office environment or home office environment
• Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations

Benefits

• RRSP or 401(k) contribution matching
• Opportunities to work with internationally renowned physicians
• Comprehensive health benefits, competitive salary
• Continued opportunities for growth & development; yearly education allowance
• Paid holiday closures

Centricity Research is committed to meet the accessibility needs of persons with disabilities in a timely manner. These accommodations will be available upon request.

We thank all candidates for their applications, however, only those candidates selected for an interview will be contacted.

Centricity Research values the health and well-being of our employees, clients and patients and as such we have instituted a COVID-19 Mandatory Vaccination policy for all employees. All candidates receiving job offers will be required to provide proof of vaccination.

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