Research Assistant (VEC)

Job Summary

Conducts a wide range of tasks that relate to clinical research fieldwork, data handling and/or the laboratory commonly developing a specialization in one area.

Organizational Status

• Interfaces with Field Coordinator, Data Coordinator, Statistician and Lab Manager.

• Interfaces with other clinical research sites disseminating data queries and facilitating quality assurance regarding data collected.

• Works in an office shared with other VEC staff. The work encourages frequent moving around and occasional lifting of boxes up to 10 kg. Will work at offsite clinics and be available to conduct evening telephone-related work

Work Performed

Performs all duties and tasks described in the Research Assistant Tech 2 position as well as the following:

Data

• Provides quality control monitoring for data collection following and interpreting GCP guidelines, ensuring accuracy, completeness, legibility and verifiability of source information.

• Tests new data entry databases for ease of use within the data management area.

• Writes user’s manual for the data entry staff.

• Documents the structure of the already developed database.

• Documents the data management process for each study.

• Performs logical checks of the data, queries and edits the data when errors are found.

• Prepares the database for the statistical team’s use and prepares the computerized data for long term storage according to VEC policies.

Recruitment

• Reviews patient charts, determines eligibility for participation based on set guidelines in the study protocol. (This requires a science or medical background).

• Obtains detailed medical histories (including ability to decide eligibility for study participation although final decision is with study coordinator or investigator(s)).

• Understands vaccines and their functions and is able to perform recruitment for studies, providing potential study participants with all the necessary information.

• Performs recruitment for both basic simple studies and complex detailed studies.

Enrolment

• Completes informed consent with study participants on studies performed by VEC. Often requires working at offsite clinics.

Study preparation

• Creates reports for retrieval of pertinent information on study participants from the computer tracking system building in appropriate safety checks.

• Creation of source documents and Case Report Forms as directed by the data manager utilizing established SOP and an existing computer design program.

• Develops custom-designed study participant tracking databases utilizing VEC SOP, following study specification requirements as directed by the study coordinator.

• Assists with database setup as directed by the data manager.

Other tasks

• Performs other duties as required.

• Provides input into study setup from implementation to study wind down.

• Provides input or basic design procedures for carrying out the tasks they are responsible for.

Consequence of Error/Judgement

Duties are performed according to operating procedures and VEC policies. Decisions are made for the tasks at hand as related to the job. Some non-routine decisions are made without consultation.

Consequences of errors in decision-making may affect the integrity of databases and/or the integrity of study outcomes. As a result the reputation of the managers, investigators and the VEC could be jeopardized.

Supervision Received

The individual is expected to know the standard tasks that need to be done for the project and carry them out independently, reporting progress to their coordinator. Supervision is limited in that tasks are assigned and the end result is reviewed. Supervision comes from the project coordinators.

Supervision Given
Provides technical guidance to other project team members. Is expected to provide training to other research assistants.

Minimum Qualifications

• Completion of a relevant technical program or a university degree in a relevant discipline and a minimum three years of related experience or an equivalent combination of education and experience.

• Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

• Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

Graduate of recognized college or university in the health care field. Experience in vaccine clinical trials. Must have experience in database management. A sound understanding of vaccines and their appropriate use. Ability to communicate effectively verbally and in writing. Ability to deal effectively with a diversity of people. Must have excellent organizational skills as they are required to work on more than one study at a time. Proven ability in accepting responsibility. This position has the option of a hybrid work arrangement.