Clinical Research Associate
Job Details
Full Job Description
Department | Clinical and
Regulatory Affairs | Status | Full-time, Exempt
|
Reports to | VP of Clinical and Regulatory Affairs | Location | Lagos, Nigeria |
Essential Functions
Roles and Responsibilities
Support the feasibility, set-up, conduct and closure of assigned clinical studies in accordance with the ICH/GCP guidelines, applicable regional regulatory requirements, and the company’s Standard Operational Procedures (SOPs).
Conduct sites evaluation, initiation, interim monitoring, and close-out visits, following the department’s procedural requirements and the study protocol.
Develop study administration documents, including study-specific informed consent documents, study manuals and plans, trial master files, case report form etc.
Participate in meetings with investigational sites, key opinion leaders and consultants as needed.
Coordinates all correspondence and respond promptly and appropriately to study questions and issues raised by assigned investigational sites.
Develop study trackers and logs for managing study conduct, as well as a reporting template for study updates.
Train site staff on the protocol, study methodology and electronic systems, as applicable.
Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through remote or on-site monitoring visits. Perform validation of source documentation. Prepare monitoring reports and letters per department’s defined timelines.
Ensure the accuracy and completeness of clinical data through (1) remote review of electronic data and documents and (2) on-site source documentation verification.
Review serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks.
Generate study queries, as needed, and work with sites to resolve the queries.
Perform all assigned tasks effectively and ensure efficient coordination with internal and external teams to set project priorities and milestones.
Ensure all project level study documentation is filed in the eTMF in accordance with company SOPs and contribute to the clinical team regarding TMF filing, maintenance and archival procedures.
Support the training/onboarding of clinical and regulatory affairs personnel and cross-functional team members.
Perform other duties as assigned.
You will also support efficient operations of our Clinical
and Regulatory Affairs department by doing the following:
Maintain professional expertise through familiarity with therapeutic area, clinical research literature and regulatory requirements.
Conduct secondary research and literature reviews to support internal reports.
Requirements
Knowledge, Skills &
Abilities
Great client-facing and internal communication skills
Great written and verbal communication skills
Solid organizational skills including attention to detail and multitasking skills
Strong working knowledge of Microsoft Office, particularly Excel, PowerPoint, and Project
Education & Certifications
Bachelor’s Degree (preferably in a life sciences discipline)
CRA certification (ACRP or equivalent) is a plus
Experience
Work Environment
The above job
description is not intended to be an all-inclusive list of duties and
standards of the position. Incumbents will follow any other
instructions, and perform any other related duties, as assigned by
their supervisor.
Equal Opportunity
Employer
54gene celebrates diversity and is proud
to be an inclusive employer. We do not discriminate based upon race,
religion, color, national origin, ancestry, sex, gender (including
pregnancy, childbirth, or related medical conditions), sexual
orientation, gender identity or gender expression, age, marital
status, genetic information, status as a protected veteran, status as
an individual with a mental or physical disability, or any other
applicable legally protected status or characteristics.
Clinical Research Associate
54gene
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