Emmes · 1 day ago
Senior Clinical Research Associate
United States
Full-time
Remote
Mid, Senior Level
4+ years expEmmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. The Senior Clinical Research Associate (CRA) is responsible for monitoring clinical study sites to ensure clinical trials are conducted in accordance with protocols and regulatory requirements.
BiopharmaBiotechnologyClinical TrialsHealth CareMedical
Responsibilities
Under minimal supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits
As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead
Documents observations and monitoring activities in a site visit report at the conclusion of the visit with minimal feedback by the report reviewer
Facilitates and oversees Action Item resolution post visit
Helps to ensure that clinical sites are conducting the study in compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations
Provides training and retraining to site staff including protocol, GCP/GDP, and other training under direction from the project CRA staff oversight lead
Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project CRA staff oversight lead
Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures
Serves as point of contact for study site personnel to answer questions and resolve study related issues under the direction of the project CRA staff oversight lead
May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc
Prepares for and attends project team meetings and provides updates on project status and site-specific performance
Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines
Participates in Investigator Meetings or other client meetings as needed
Assists with filing and archiving of study documents
Assists in preparing sites for audits and may provide support and cooperation during audits/inspections (including translation to Auditor if needed)
May assist with coordination of clinical study supplies
May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority
May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans
Performs site management activities as required
Other duties as assigned
Qualification
Required
Bachelor's degree (scientific discipline preferred) or equivalent work experience
At least 4-5 years of relevant monitoring experience (on-site and remote)
Proficient with MS Office Suite
Excellent computer and organizational skills
Exceptional level of attention to detail required
Ability to work on varying projects and exercise critical thinking with minimal oversight
Self-starter who can work remotely and a team player who can work cross functionally with minimal oversight
Expertise in clinical research operations, including interpretation and implementation of country regulations/ICH guidelines, as required per their role as a CRA
Excellent organizational, interpersonal, and communication skills (both oral and written)
Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment
Expertise 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
Company
Emmes
Emmes is a contract research organization that offers clinical research services for public health and biopharmaceutical innovation.
1001-5000 employees
H1B Sponsorship
Emmes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (6)
2022 (11)
2021 (6)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Behrman Capital
2022-06-21Acquired
2019-03-04Private Equity
Leadership Team
Peter Ronco
Chief Executive Officer
Recent News
2025-09-20
2025-01-18
2024-12-10
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