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
- 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