Site Start-Up Specialist

PSG Global Solutions; Irvine (CA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Site Start-Up Specialist to lead and support clinical trial site initiation activities in a dynamic and fast-paced environment. This role is crucial for ensuring that all necessary documentation is in order and that sites are ready for timely initiation. The ideal candidate will possess strong leadership skills and a deep understanding of compliance in the pharmaceuticals and medical products sector. Join a forward-thinking company that values precision and excellence in clinical research operations, and make a significant impact in the healthcare industry.

Qualifications

• Strong understanding of clinical trial processes and regulations.
• Ability to manage documentation and ensure compliance.

Responsibilities

• Support Site Start Up Teams in executing clinical trial activities.
• Manage clinical site initiation and ensure compliance with regulations.

Skills

Leadership

Compliance Knowledge

Documentation Management

Clinical Trial Knowledge

Education

Bachelor's Degree in Life Sciences

Relevant Certifications

Job description

Description

We're looking for a Site Start-Up Specialist, working in Pharmaceuticals and Medical Products industry in Irvine, California, United States.

Job description:

• Provides support and/or leadership to their assigned Site Start Up Teams in the execution of all Site Start Up activities and timely initiation of sites for clinical trials.
• Performs all the roles encompassed in the preceding grade levels within the job family as required by the organization. Conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures.
• Directly manages clinical site initiation activities.
• Reviews approval of clinical study informed consent forms and patient privacy authorization forms.
• Ensures all required documentation and training has been properly executed, received in-house and filed appropriately. Completes all required debarment and medical license checks.
• Assures all requirements are met for IP release.