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 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 patient volunteers, 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

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

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

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