Clinical Research Associate

As a Clinical Research Associate (CRA) at 54gene, you will play a critical role in contributing to the organization’s success by supporting and contributing to all aspects of the Clinical and Regulatory Affairs department (ClinReg) activities for assigned studies. You are accountable for achieving successful execution of assigned studies in accordance with Good Clinical Practices, applicable regional regulatory requirements, and company’s policy. You will work closely with the clinical project/study manager and other team members to ensure that all study monitoring activities are conducted according to the study requirements. You are required to be organized, analytical and thorough in owning, coordinating, and managing all aspects of clinical studies from inception to completion within the set timeframe, budget, and scope. You will think quickly and strategically when identifying and addressing challenges; and, you will display sensitivity and high levels of emotional intelligence when interacting with all stakeholders.

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. 
  

• Proactively identify and resolve issues and participate in process improvement initiatives as required.
  

• 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

• Working knowledge of research concepts, practices, ICH GCP Guidelines, and regulatory requirements for clinical trial management.  Knowledge of regulations in Nigeria as they apply to clinical research is a plus.
  

• 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

• 1 or more years of clinical operations is required
  

Work Environment

This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 30 % of work time.

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.

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