Clinical Research Associate at 54gene

Job Description

• 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.

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
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

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

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.