Research Assistant

Centricity Research; Ottawa; On-site; CAD 45,000 - 60,000; Full time

Job summary

A leading company in clinical research is seeking a Research Assistant to aid in various administrative and clinical activities related to ongoing studies. The position requires strong communication skills, attention to detail, and the ability to manage multiple tasks efficiently. Opportunities for professional growth, engagement with renowned physicians, and competitive compensation are offered in this dynamic environment.

Benefits

Comprehensive health benefits

RRSP or 401(k) contribution matching

Paid holiday closures

Yearly education allowance

Employee appreciation days off

Qualifications

• Strong understanding of clinical study protocols and safety regulations.
• Experience in clinical research or healthcare settings.
• Ability to perform phlebotomy and other medical procedures.

Responsibilities

• Conduct clinical studies as per protocols and ensure participant safety.
• Support study participant recruitment, screening, and enrollment.
• Perform data collection and ensure accuracy in documentation.

Skills

Communication Skills

Attention to Detail

Time Management

Teamwork

Clinical Skills

Analytical Skills

Education

College/University Degree or clinical research diploma

Clinical Research Certificate

Tools

MS Word

Excel

Outlook

Job description

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)
• 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