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Clinical Research Associate I

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Emmes

Jan 12

  • Job
    Full-time
    Junior Level
  • Research & Development

AI generated summary

  • You need a Bachelor's in a scientific field or equivalent experience, 1-2 years of monitoring experience, MS Office proficiency, attention to detail, strong communication skills, and the ability to collaborate.
  • You will conduct monitoring visits, review compliance, document findings, train site staff, and assist with study materials, audits, and recruitment under supervision.

Requirements

  • Bachelor’s degree (scientific discipline preferred) or equivalent work experience
  • At least 1-2 years of relevant monitoring experience (on-site and remote)
  • Proficient with MS Office Suite
  • Excellent computer and organizational skills
  • High level of attention to detail required
  • Ability to work on varying projects and exercise critical thinking
  • Self-starter who can work remotely and a team player who can work cross functionally with some oversight
  • Knowledgeable 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
  • 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

Responsibilities

  • Under 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.
  • 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.

FAQs

What qualifications are required for the Clinical Research Associate I position?

A Bachelor’s degree in a scientific discipline or equivalent work experience is required.

How much experience is needed for this role?

At least 1-2 years of relevant monitoring experience, both on-site and remote, is required.

What are the primary responsibilities of a Clinical Research Associate I?

The responsibilities include conducting remote and on-site monitoring visits, ensuring compliance with protocols and regulations, training site staff, documenting observations, and facilitating action item resolutions, among other duties.

Is proficiency in computer skills necessary for this position?

Yes, proficiency with the MS Office Suite and excellent computer skills are required.

What types of studies will the Clinical Research Associate I be involved with?

The position involves monitoring clinical trials in various therapeutic areas including cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Will the Clinical Research Associate I have opportunities for training?

Yes, the CRA will provide training and retraining to site staff, including protocol and GCP/GDP training.

What soft skills are important for this role?

Excellent organizational, interpersonal, and communication skills, along with problem-solving abilities and the capacity to adapt to a dynamic environment, are essential.

Is there a requirement to attend meetings?

Yes, the Clinical Research Associate I is expected to prepare for and attend project team meetings and provide updates on project status and site-specific performance.

What is the work environment like for this position?

The work environment is collaborative, focusing on both performance and people-oriented culture, with the ability to work remotely and cross-functionally with other team members.

How does Emmes Group support the ongoing development of its employees?

Emmes promotes innovation and encourages employees to contribute to transforming clinical research, providing opportunities for growth and development within the company.

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Emmes

The Industry’s First Native Digital and AI Specialty CRO

Science & Healthcare
Industry
1001-5000
Employees

Mission & Purpose

Emmes is a global, full-service Clinical Research Organisation (CRO) that provides research support to various sectors, including pharmaceuticals, biotechnology, and government agencies. The company specialises in the design, execution, and analysis of clinical trials, focusing on developing new treatments and therapies that improve patient outcomes. Emmes' ultimate goal is to advance public health through innovative research and by helping bring safe, effective medical products to market. Their purpose is to bridge the gap between scientific discovery and patient care, ensuring that new medical interventions are thoroughly tested and validated.

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