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Lead, Clinical Research Associate - US

3 weeks ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Celerion

Celerion

Celerion is a pioneer in early clinical research, offering Applied Translational Medicine services worldwide to expedite drug development processes.

Pharmaceuticals
251-1K
Founded 2010
View All Jobs 7

Description

  • Provide leadership, supervision, coaching, and performance management for Clinical Research Associates and contractors.
  • Hire, onboard, train, and assign staff to clinical projects while managing workload and resource allocation.
  • Approve timesheets and expense reports and ensure timely administrative completion by the team.
  • Develop and implement training programs, best practices, and process improvement initiatives.
  • Oversee monitoring activities to ensure compliance with contracts, monitoring plans, SOPs, GCP, and regulatory requirements.
  • Support development and review of study materials, monitoring plans, CTMS updates, and tracking of visits, queries, and issues.
  • Coordinate with sponsors, clinical project managers, and study team members to resolve project issues and support meetings.
  • Participate in audits, inspections, follow-up activities, and regulatory submission support.
  • May perform CRA duties on selected studies when needed.
  • Perform on-site and in-house tasks and other duties as assigned.

Requirements

  • Bachelor's degree in a biomedical-related field, life sciences, or equivalent field.
  • At least 5 years of experience in clinical operations or a related discipline in CRO or pharmaceutical industry.
  • Minimum of 3 years of onsite monitoring experience.
  • People management skills.
  • Excellent oral and written communication skills in English.
  • Strong organization, multitasking, judgment, analytical, and time management skills.
  • Profound knowledge of Good Clinical Practice, 21 CFR Part 11, and other relevant regulatory requirements.
  • Experience conducting feasibility, site qualification, initiation, routine monitoring, and close-out visits.
  • Experience with investigational product accountability, Trial Master Files, and SAE handling.
  • Ability to travel for both pre-planned and impromptu meetings/visits.
  • Ability to work independently and as part of a team.
  • Strong attention to detail, confidentiality, and computer literacy.
  • Preferred: commitment to continuous training and keeping current with industry standards and regulatory developments.

Interested in this position?

Apply directly on the company website

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