[Hiring] Sr. In-House CRA @Emmes Group

Role Description

The Senior 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 Sr. In-House CRA may assist in program level status tracking and reporting across multiple studies. The Sr. In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

• Under the high level supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)
• Possesses working 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, etc.).
• Has solid knowledge of Good Clinical Practices and country regulatory requirements.
• Independently collects, reviews, maintains, and tracks required essential documents.
• Performs upload of essential documents into the trial master file.
• Independently communicates and coordinates effectively with internal project staff members and site staff.
• Independently completes IRB/EC submissions for sites or submits to central IRB/EC on behalf of the site.
• Provides project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
• Provides mentorship and training to junior staff on the project.
• Assists in audit preparation activities as needed.
• Assists the CRA in Issue and Action Item (AI) resolution post visit and assists with tracking AIs to completion.
• Tracks site training.
• Tracks site recruitment efforts and collects/reviews site screening logs.
• Assists with the review of the database to assess data currency and may assist site teams with resolving data queries/discrepancies.
• Reviews site specific language in informed consent forms prior to submission to the IRB/EC.
• Assists with preparing and independently conducts training and retraining of site staff.
• Prepares meeting agendas and meeting minutes.
• May assist in preparing study documents.
• May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
• May assist experienced CRA in the conduct of remote and/or on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.
• May perform remote review and monitoring of Informed Consent Forms and other source documents.
• May assist with preparation of DSMB meeting materials.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in a scientific discipline preferred, or directly applicable work experience preferred.
• 1-3 years of relevant clinical research experience (as a CTA, in-house CRA, study coordinator, etc.) required.
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• High attention to detail required.
• Ability to work on varying projects and exercise critical thinking.
• Self-starter who can work independently and a team player who can work cross-functionally with limited oversight.
• Knowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required.
• Excellent 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.

Benefits

• Flexible Approved Time Off.
• Tuition Reimbursement.
• 401k Retirement Plan.
• Work From Home Anywhere in the US.
• Maternal/Paternal Leave.
• Casual Dress Code & Work Environment.