Clinical Research Coordinator

$62,400 - $72,800/Yr

Actalent - Burlingame, CA

Full-time - Mid Level

Hybrid - Burlingame, CA

10,001+ employees

Administrative and Support Services

About the position

The Clinical Research Coordinator at Actalent serves as the primary communication link between the Sponsor or CRO and the medical site. This role is crucial in ensuring that all aspects of clinical trials are conducted efficiently, including patient enrollment, data management, and compliance with regulatory requirements. The coordinator will assist in scheduling monitoring visits, track patient enrollment, and maintain accurate documentation throughout the study process.

Responsibilities

• Act as the main line of communication between the Sponsor or CRO and the site.
• Ensure response to feasibility questions are provided in due time.
• Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.
• Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
• Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
• Maintain study specific and general tracking of documents at the site level.
• Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
• Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.
• Proper handling, accountability and reconciliation of investigational products and clinical supplies.
• Collect, handle and maintain all site-specific regulatory documents as needed.
• Facilitate and support the contract and budget negotiations at the site level.
• Support Investigator and Site payments and processes as needed.
• Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
• Prepare for and participate in onsite study audits or regulatory agency inspections.

Requirements

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• 2-3 years of site coordinating experience is required.
• Ability to multitask across various protocols.
• Ability to work on Saturdays.
• Experience with eSource systems (preferred).
• Experience in Renal therapeutic areas.
• Blood draws, EKGs, patient interaction.

Nice-to-haves

• Experience with eSource systems (preferred).
• Experience in Renal therapeutic areas.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)