Clinical Research Associate I

Remote
Full-Time
Part-Time
Internship
DESCRIPTION

Responsible for managing and monitoring clinical sites to assure compliance with applicable regulatory requirements and Good Clinical Practices. As part of the clinical operations team ensures and works across the project team to ensure site relationships are maintained, clinical data is entered and cleaned and up to date metrics are tracked and relayed to the project team as appropriate.

Duties & Responsibilities

Overnight travel 20%-80%, anywhere in the U.S.

Assist the clinical team with a variety of study-related activities

  • Maintain site files and study documentation, assist with the management and QA of clinical
    regulatory and critical documents
  • Assist with logging, scanning and filing of clinical regulatory and other documents
  • Manage documentation and accountability of investigational product (drug, device or diagnostic
    study products)
  • Assist with and track: site/study activities, study supplies, resolution of data queries, site
    enrollment, data queries and their resolution and SAEs
  • Assist with the identification, selection and qualification of principal investigators (PIs)
  • Assist with the training and site initiation of clinical sites for projects

Perform remote and on-site monitoring activities per the Clinical Monitoring Plan (CMP)

Conduct or attend Site Initiation Visits (SIVs)

Validate and collect study data for data cleanliness

Manage enrollment issues at the site level, resolution of data queries and site performance
issues

Assist with collection of site study metrics for overall study performance

Audit, manage and collect clinical regulatory documents

Ensure site compliance with regulatory requirements and Good Clinical Practices (GCPs),
and Proxima and client policies and procedures

Conduct study site close-out visits (COVs)

Attendance at company meetings, completion and proper submission of timesheets and
documentation of training

Adherence to Proxima or client Standard Operating Procedures (SOPs) (as applicable)

Professionally represent Proxima in business interactions

REQUIRED Experience

At least 3 years experience in sponsor, clinical or CRO environment.

Working knowledge of clinical research industry and requirements for MedTech and/or BioTech industries.

Working knowledge of Good Clinical Practice (GCP) or applicable regional regulations and guidance.

preferred Experience
REQUIRED SKILLS

BA, BS or Associate’s degree or equivalent in a scientific or healthcare field or a minimum of 6 months clinical trial experience. Must have a thorough understanding of current GCP, ICH-E6, ISO 14155 and FDA regulations pertaining to clinical research and be able to interpret and implement this understanding. Familiarity with common medical terminology is required. Strong interpersonal skills. Excellent oral and written communication skills. Ability to articulate issues. Self-management skills, including ability to multi-task. Attention to detail and accuracy in work. Strong problem solving and interpersonal skills. Excel, Word, timeline management and computer skills (proficiency using Microsoft Office or similar). Ability to maintain and implement confidentiality on behalf of Proxima Clinical Research and its clients.

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