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.
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
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
Core Competencies/Skills
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
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
Modern medical office environment or home office environment
Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations
Required to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations
Some positions may require overnight/weekend hours
Benefits
Opportunities to work with internationally renowned physicians
Comprehensive health benefits, competitive salary
RRSP or 401(k) contribution matching
Continued opportunities for growth & development; yearly education allowance
Paid holiday closures and employee appreciation days off
Seniority level
Entry level
Employment type
Other
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology Research
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