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Senior In-House CRA

Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 
Maryland (USA), United States

Offer summary

Qualifications:

Bachelor's degree in a scientific discipline preferred, 2-3 years of relevant clinical research experience, Proficient with MS Office Suite, High attention to detail required.

Key responsabilities:

  • Assist with operational activities for clinical trials
  • Communicate and coordinate with internal project staff and site staff
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Emmes Large http://www.emmes.com
1001 - 5000 Employees
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Job description

Overview

Senior In-House CRA

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 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.

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 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.

Qualifications

  • 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

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!

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Find us on LinkedIn - Emmes

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.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication
  • Time Management
  • Teamwork
  • Critical Thinking
  • Detail Oriented

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