About this role

  • Posted on

  • Location

    Pennsylvania

  • Salary

    $0.00 - $100.00 per annum

  • Type

    Contract

  • Division

    Pharmaceutical Scientific & Clinical Development Jobs

  • Reference

    BBBH19858UK_1626082345

  • Start date

    ASAP

  • Managing this role

Consultant

Urszula Kaldi

+44 (0) 203 8543 089

urszula.kaldi@xplorepharma.com

154-158 Shoreditch High Street

Description

Type: 12 months contract
Client: Biotech
Location: Remote, East Coast, US

Sr. Clinical Research Associate is responsible for assisting with the management of clinical trial, site management, data review and cleaning, and the implementing and conduct of monitoring oversight visits of clinical trials. May lead implementation of procedures during the study start up, maintenance and close out. Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives. Identifies projects/tasks and works with Clinical Project Manager to complete. Critical Thinking, ability to identify urgent issues and manage priorities for multiple tasks. Demonstrates ability to carry out all assigned tasks with minimal supervision. In collaboration with manager maintains oversight on protocol execution quality and vendors performance.

Key Accountabilities/Core Job Responsibilities:

  • Acts as main point of contact for vendors, sites and cross-functional teams as assigned. Escalates issues to the Clinical Project manager as appropriate.
  • Conducts oversight quality of monitoring visits and co-monitoring visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate clinical trial regulatory compliance
  • Assists in CRF design and CRF guidelines
  • Develops study tools and guidelines to be utilized by study sites
  • Assists in the process used to evaluate and select potential investigators and sites
  • Prepares monitoring reports per SOPs
  • Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
  • Understands study timelines and manages sites to meet timelines
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Proactively identifies and works to resolve enrollment and data completion issues
  • Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
  • Reviews monitoring reports and track resolution of open items
  • Responsible for the oversight and mentoring of junior team members
  • Participates in evaluation, selection, and training of vendors and sites
  • Reviews site’s informed consents against the consent template for presence of all GCP requirements and protocol specific information. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand
  • Develops basic skills in writing informed consent templates, protocol and other documents. Applies knowledge of regulatory requirements/SOPs to documents
  • Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy
  • Ensures study records are auditable both at investigational sites and in-house
  • Responsible for tracking IND Safety Reports for assigned sites
  • Initiates IMP shipments and ensures that drug supplies are adequate for assigned studies
  • Assists Clinical Project Manager with the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies
  • Responsible for initiating and tracking quarterly site payments
  • Responsible for coordinating and leading various functional area projects and tasks
  • Develops basic skills in functional area team leadership
  • Maintains completion of corporate training on standards, policies and work procedures by due date

Qualifications:

  • Good verbal and written communication skills are required. Attention to detail and organizational skills
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • 3+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including at least 1-year previous experience as a CRA.
  • Experience in clinical research at either a hospital or pharmaceutical/biotech company
  • BS/BA degree in a life science, RN, or related field
  • Ophthalmology experience is preferred

Travel: May need to travel up to 25% of the time

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