The Judge Group

Clinical Research Site Manager (1042148)

The Judge Group South San Francisco, CA
The Judge Group

Clinical Research Site Manager (1042148)

The Judge Group South San Francisco, CA
2 months ago 179 applicants

See who The Judge Group has hired for this role

Location: South San Francisco, CA, USA

Salary: $120,000.00 USD Annually - $135,000.00 USD Annually

Description: Our client is currently seeking a Clinical Research Site Manager

Key Responsibilities

This job will have the following responsibilities:

Clinical Trial Management

  • Oversee and monitor clinical trial activities at investigative sites, ensuring compliance with protocols, regulatory requirements (GCP and ICH), and company standards.
  • Assist in Site Initiation Visits (SIVs) and training of any new site staff added post-Investigator Meeting and study start.
  • Perform site troubleshooting and issue spotting, proactively identifying and resolving challenges to ensure the smooth progress of clinical trials.
  • Collaborate with cross-functional teams internally to address site-related issues and implement effective solutions.

Site Engagement And Relationship Building

  • Build and maintain strong relationships with investigators, site staff, and key stakeholders to foster a collaborative and supportive environment.
  • Act as a liaison between the company, CRO (Contract Research Organization) and investigative sites, ensuring clear communication and efficient resolution of site-related queries. Provide training and support to site staff, as needed, to enhance their understanding of protocols, procedures, and compliance with requirements.

Clinical Data Review And Reporting

  • Review and verify clinical trial data, ensuring accuracy and completeness in accordance with protocols and regulatory standards.
  • Perform clinical quality review of data and source documents to ensure internal consistency of data and concordance with expected clinical profiles across data sources.
  • Conduct reviews of clinical charts (paper and electronic), source documents, and case report forms.
  • Assist in the development of monitoring tools for use by CRO and other team members.
  • Prepare regular reports on site performance, patient recruitment, and other relevant metrics, providing updates to internal teams and stakeholders.

Regulatory Compliance And Documentation

  • Build and maintain strong relationships with key internal and external stakeholders, including investigators, KOLs (Key Opinion Leaders), CROs, and regulatory agencies.
  • Stay updated on relevant regulations, guidelines, and best practices related to clinical research and ensure site compliance with these standards.
  • Assist in the preparation of regulatory submissions and documentation, collaborating with regulatory affairs teams as necessary.

Continuous Improvement And Process Optimization

  • Identify opportunities for process optimization and improvement in clinical trial conduct, site engagement, and monitoring activities.
  • Contribute to the development and implementation of best practices and standard operating procedures to enhance the efficiency and quality of clinical research operations.

Qualifications

  • Bachelor's degree in life sciences, pharmacy, nursing, or related field (Master's degree preferred).
  • Minimum of 5 years of experience in clinical research, with a strong preference for Psychiatry background, preferably in a biotech or pharmaceutical setting.
  • Prior psychometric rater experience a strong plus
  • Strong understanding of GCP (Good Clinical Practice) guidelines, regulatory requirements, and industry standards. CCRC and GCP current certification a strong plus.
  • Excellent communication and interpersonal skills, with the ability to build rapport and maintain positive relationships with diverse stakeholders.
  • Detail-oriented, analytical, and proactive, with the ability to identify issues and implement effective solutions.
  • Proficiency in using clinical trial management systems and related software tools.
  • Willingness to travel to investigative sites on a frequent basis

Travel Requirement

This position requires regular regional in-state and out-of-state travel, the USA, approximately up to 50 to 75% of the time.

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Staffing and Recruiting

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