Clinical Data Entry Associate

3 weeks ago

Montréal, Canada Genesis Global Group Full time

**Job Summary**: Works under general supervision of the Data Management hierarchy as required performing tasks in the conduct of clinical trials.

**Essential Functions**: The following duties represent the principle job duties however they are not all inclusive:

- Adheres to implemented Quality Assurance processes

Tracks Case Report Forms (CRF) reception and follows up if there are missing pages until resolutionReviews CRF and other study material to determine data accuracy and completeness and to detect study protocol and data discrepanciesPerforms data entry and/or double-entry verification of CRF into study database Tracks the reporting of adverse events (including serious and non-serious)Issues Data Clarification Forms (DCF) to sites to resolve data discrepanciesAssists in the preparation of packages for the sites/investigators, which may include study documents, the investigational product and other study materials Maintains inventory of study documentsParticipates in department and project audits, if required

**Additional Responsibilities**:
**Knowledge of**:

- MS Office
- Electronic systems currently in use at JSS Medical Research to process data for clinical trials
- Medical Terminology
- Requirements of Good Clinical Practices
- Requirements of Good Documentation Practices
- Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

**Ability to**:

- Maintain and exhibit discretion at all times when handling confidential information
- Research and verify information to ensure accuracy
- Enter accurate data as instructed
- Communicate effectively orally and in writing
- Assume multiple and concurrent tasks and responsibilities
- Establish and maintain cooperative and effective working relations with fellow employees
- Demonstrate integrity, respect, professionalism, commitment and accountability

**Job Qualifications**: General Knowledge, Skills, and Abilities (KSA’s) required

**Experience and Education**:

- Minimum CEGEP degree or one year relevant experience
- Ideally 1 year experience directly related to data entry

**We Offer**:

- Competitive Salary
- Medical, Dental & Vision Insurance
- Short and Long Term Disability
- Life Insurance
- Dependent Care Flex Spending Account
- Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD)
- Legal Plan & Identity Theft Protection
- 401(k) Plan
- Paid Vacation & Holiday
- Business Casual Environment
- Credit Union

Genesis Global Group is an equal opportunity employer.

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