Clinical Research Assistant

**GENERAL RESPONSIBILTIES**
- **Records Data**
- Accurately and properly handles study data
- Follows supervisor’s directions as indicated by the SOP in the recording of data
- Locates appropriate paperwork efficiently
- Consistently writes in a legible manner
- **Organizes and updates binder as needed**
- Demonstrates ability to efficiently and effectively organize material following the Cliantha binder format
- Updates appropriate binder data/information on a daily basis
- **Interviews panelists, as applicable**
- Greets and welcomes study participants to Cliantha
- Verifies accuracy of information the study participant gave to the recruiting office during the screening process
- Demonstrates ability to put study participant(s) at ease, even when asking delicate or sensitive questions
- Uses simples language to explain steps of specific test protocol and confirms the panelist’ understanding
- Provides study participants with directions to appropriate testing site
- Exhibits ability to synthesize study participants’ information and ask pertinent follow up questions
- Schedules required study participant(s) follow up visits and explains the importance of continued participation
- Obtains IRB approved informed consent (ICF), medical histories, and demographic information from potential volunteers
- **Completes various study procedures**
- Performs necessary procedures required per protocol to accomplish the screening visit such as but not limited to ECGs and Vital Signs
- Answers questions, reviews protocol, and works closely with the screening coordinator, recruitment and regulatory department.
- Asks for clarification and assistance as needed
- Study related tasks (such as Meals distribution, Recording, Visual Acuity, Installation, Assembly, Check In procedures, baggage search, or as needed.)
- Completes all study related activities following the sites SOPs, policies, and protocol in order to meet the study timelines
- Protects sponsor confidentiality by limiting discussion of ongoing protocols with monitors and other industry representative
- Communicates status of task(s) to be completed to supervisor
- Shows pride in work by completing all tasks in a neat and accurate manner
- **Performs simple data entry**
- Utilizes data program software or Cliantha provided sheets, accurately entering and editing simple data
- **May be responsible for Sample Log-ins and Returns**
- Accurately and according to SOPs, identifies, weighs and legibly records each sample item against protocol requirements
- Stores samples neatly and efficiently in appropriate place, as defined by study protocol or directed by supervisor
- Verifies accuracy of package content against invoices
- Packages test samples properly and promptly, and returns samples to designated source, as specified by the protocol
- **May conduct ‘on-the-job’ training with the associate**
- Explains step-by-step procedure using clear and simples language
- Uses proper technique in demonstrating step-by-step procedure dictated by SOP
- Observes associate practicing procedure and provides corrective feedback
- Utilizes appropriate job aids to assist in training
- Records and documents training for associate’s training binder
- Provide administrative support as required, including but not limited to copying, numbering, binding and archival of project and supporting documentation
- **May calibrate equipment**
- Conducts accurate calibration of equipment as detailed in SOPs
- Immediately reports equipment problem/malfunction to appropriate associate
- Under close supervision, may be responsible for sample(s) preparation
- Demonstrates the ability to accurately prepare samples following supervisor’s explicit calculations/instructions
- Demonstrates ability to properly use lab equipment in accordance with the SOPs to accurately fulfill requirements of the study protocol
- Works with others in a cooperative manner
- Participate in training sessions and protocol implementation
- Execute other duties that may be required by other members of the management team as training and experience allows

**Qualifications**:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Graduation for high school, GED or demonstrated equivalent with previous medical knowledge.

**Skills and Abilities**:

- Ability to follow directions and complete assignments
- Knowledge of proper English grammar
- Knowledge of basic computer skills (keyboarding, data entry)
- Ability to write neatly and legibly
- Ability to work with others in a cooperative manner
- Demonstrated knowledge of Cliantha Research policies, regulatory requirements and quality standards (e.g. GCP, ICH GCP)

**Job Type**: Part-time

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Winnipeg, MB: reliably commute or plan to relocate before starting work (preferred)

**Education**:

- AEC / DEP or Skilled Trade Certificate (preferred)

Shift availability:

-