Clinical Data Entry Associate

3 days ago

Scarborough, Canada Pharma Medica Research Inc. Full time

Pharma Medica Research is a full-service Contract Research Organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are currently looking for a CDM Data Coordinator to join our team in Scarborough The primary function of the CDM Data Coordinator in the Clinical Data Management department is to enter required data from the clinic source documents into an electronic data capture (EDC) system in accordance with timelines, Pharma Medica Research Inc. (PMRI) Standard Operating Procedures (SOPs), Good Clinical Data Management Practices (GCDMP), Data Entry Guidelines (DEGs) and conventions. This position reports to the Manager, CDM and/or designate.

**Duties and Responsibilities**
Responsibilities include but are not limited to:

- Perform User Acceptance Testing (UAT) of the study electronic Case Report Forms (eCRFs) from a data entry perspective to ensure the functionality of the programmed edit checks, and the flow, content, and ease of use of the eCRFs.
- Accurately enter required data from the clinic source documents into the EDC system and/or validated Excel spreadsheets in accordance with study timelines, applicable guidelines, and procedures, while ensuring the quality of the data entry meets an acceptable query rate.
- Code medical history, concomitant medications and adverse events in the EDC system using the Medical Dictionary for Regulatory Activities (MedDRA) and the WHO Drug Global B3 Dictionary.
- Respond to data queries in a timely manner.
- Manage laboratory data by compiling and tracking laboratory requisitions, requesting electronic data transfers from laboratory vendor, importing transferred data into the EDC system, and following up with Study Coordinators regarding pending post-study repeats.
- Generate/review tables from the EDC system, where applicable, for incorporation into the Clinical Study Reports.
- Participate in database locking activities ensuring all data has been captured, discrepancies addressed, and timelines are met.
- Collaborate with CDM staff, clinic staff (i.e., Study Coordinators, Clinical Research Associate, Quality Assurance, Quality Control, and Subject Screening), and Sponsor Monitors on data entry aspects of studies.
- Follow-up with clinic staff to resolve discrepancies or obtain clarification regarding information recorded on the clinic source documents.
- Provide regular updates to Manager, CDM and/or designate regarding assigned data entry tasks to ensure timely completion of all deliverables.
- Provide hands-on training for new Data Entry staff and Co-op students.
- Perform other duties as required such as data review, source data verification (SDV).

**Job Knowledge**

Minimum level of academic or formalized training:

- Diploma or equivalent in scientific or health-related field;
- Strong knowledge of medical terminology.

Minimum amount of practical work experience:

- 1 year experience in data entry in a clinical research environment, preferably using electronic data capture.

**Other Requirements**
- Ability to work both independently and as part of a team;
- Computer proficiency, especially with MS Windows/Word/Excel
- Good communication skills including both verbal and written
- Good interpersonal skills
- Excellent attention to details and accuracy
- Strong organizational and problem-solving skills
- Ability to display a positive attitude, even when under pressure due to tight timelines.

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