Research Assistant

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.

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