[Hiring] In-House Clinical Research Associate @Emmes Group

Role Description

The In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

• Under the supervision of the project site management staff oversight lead (e.g., Clinical Trial Manager, Lead CRA, Clinical Project Manager).
• Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements).
• Knowledge of Good Clinical Practices and country regulatory requirements.
• Collects, reviews, maintains, and tracks required essential documents, assessing completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
• Uploads essential documents into the trial master file.
• Communicates and coordinates effectively with internal project staff members and site staff.
• Assists project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
• May assist in audit preparation activities as needed.
• May assist the CRA in Issue and Action Item (AI) resolution post-visit and assists with tracking AIs to completion.
• Tracks site training.
• May assist with feasibility and site activation processes in collaboration with clinical operations counterparts.
• May assist in preparing study documents.
• May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
• May track site recruitment efforts and collect review site screening logs.
• May assist with the review of the database to assess data currency and may assist site teams with resolving data queries discrepancies.
• May assist on-site CRA in the conduct of remote and/or on-site monitoring visits such as site initiation visits, interim routine monitoring visits, and closeout visits.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in a Scientific discipline (Required).
• Less than 1 year of previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.).
• Proficient with MS Office Suite.
• Good computer and organizational skills.
• High attention to detail required.
• Ability to work on varying projects and exercise critical thinking.
• Self-starter and a team player who can work cross-functionally with heavy oversight.
• Proficient in organizational, interpersonal, and communication skills (both oral and written).
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment.
• Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities.
• Ability to collaborate with internal and external colleagues and work well in a team-oriented setting.

Company Description