Job Description

We are seeking a Clinical Trials Assistant/Medical Data Entry Assistant to work in a fast paced Clinical Trials Site in the south end of Winnipeg.

Responsibilties:

Recruitment of study participants (e.g. identifies and pre pre-screens potential subjects, obtains informed consent, conducts and administers questionnaires or other data collection tools)

Plans, implements and coordinates all aspects of data collection and source documentation, as per policy and ICH/GCP guidelines, and prepares study binders for coordinator patient visits

Enters data and tracking logs into appropriate portals accurately and within the time frame set out

Reviews data queries and responds within the time frame set out

Identifies problems and challenges and reports them to the PI or SubI or other health care team member

Ensures that all lab kits are ordered and inventory maintained, as well as prepared in advance, checked for expiry dates, and ready for use

Communicates with all members of the team to ensure accurate information is reported and appropriately documented

Prepares study related documents including adverse events documents, protocol deviations, and more

Process labs, prepares relevant documentation, and ensures that specimens are prepared and sent according to protocol

Administers or assists in the administration of IP to patients and orientates patients on study visits and self-administration if required

Assesses study: related literature; and liaises with sponsor for monitoring/audits

Participates in Investigator meetings, SIV's, Study monitor visits and Study Close out visits and participates in the boxing and scanning of closed studies in adherence with sop's

Additional duties may include:
Obtaining vital signs; monitoring patients during injections; specimen collection/handling; providing direct care to patients under the supervision of the physician; documenting procedures, operating and maintaining laboratory equipment; acting as liaison and networking with other members of the team or other interested parties.

This position requires an individual with a keen eye for detail, who is highly organized, thorough, and responsible. Knowledge and understanding of medical teminology and clinical trials processes, procedures, safety, and specimen handling is an asset. Experience drawing blood is an asset, but not a requirement. This position is daytime hours, between the hours of 8:00 and 4:30, and will begin as soon as possible. This position is a term position with the opportunity to apply for other internal positions if available.

Job Types: Full-time, Part-time, Temporary
Contract length: 3-10 months

Education:

Secondary School (required)
Work Location: In person