In-House CRA II

Overview

In-House CRA II US Remote Emmes Group

Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us! Primary Purpose The In-House Clinical Research Associate II (IH-CRA II) 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 II may also be referred to as a Clinical Trial Associate on some contracts.

Responsibilities

• Under the supervision of the project site management staff oversight lead i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.
• 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, etc.
• Knowledge of Good Clinical Practices and country regulatory requirements.
• Collects, reviews, maintains, and tracks required essential documents.
• Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
• Upload 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.

Qualifications

• Bachelor's Degree Life Sciences, Nursing, Clinical Research, or a related scientific discipline required.
• 1-3 years Clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.) required.
• 1 year Technician or Technologist (scientific discipline preferred) or directly applicable work experience preferred.
• Why work at Emmes?
• At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program.
• We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment

CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status. #LI-Remote