Senior In-House CRA

Senior In-House Clinical Research Associate

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

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.

Primary Responsibilities

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 in order 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. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.

· 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 collect/review 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.

· Other duties as assigned.



Experience

· Bachelor's degree (scientific discipline preferred) or directly applicable work experience preferred

· Incumbent will typically possess at least 2-3 years of relevant clinical research experience, (as a CTA, in-house CRA, study coordinator, etc.)

· 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/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

Emmes requires all US -based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

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:

· Unlimited Approved Leave



· Tuition Reimbursement



· 401k & Profit Sharing Plan

· Work From Home Anywhere in the US



· Maternal/Paternal Leave



· Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.