Psychometric Reader, Clinical Research Manager

Kelly® Science & Clinical is seeking a Clinical Research Psychometric Rater and Manager for a fulltime, direct hire position with a pharmaceutical client in South San Fran, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

No C2C

Must have extensive experience as a Psychometric Rater (must be clearly stated on resume)

We are seeking a highly motivated and versatile Clinical Research Site Manager / Clinical Rater to join our client's team. In this role, you will play a pivotal part in the successful execution of their clinical trials and oversight of investigative site activities. The ideal candidate will have a strong background in clinical research (preferably in Psychiatry), exceptional problem-solving skills, and the ability to build strong relationships with site staff and stakeholders.

KEY 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 Pre-Selection Visits (PSV) and Site Initiation Visits (SIV) 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, clinical assessments, 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.
• Data literacy, including analyzing, interpreting, and questioning data. Develop analytical reports to identify patterns and trends at the subject, site and study level.
• Conduct reviews of clinical charts (paper and electronic), source documents, and case report forms.
• Assist in 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, Key Opinion Leaders (KOL), 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:

• Master's degree in related field, may be substituted with experience.
• Minimum of 5 years of experience in clinical research, with a strong preference for Psychiatry background, preferably in a biotech or pharmaceutical setting.
• Psychometric rater experience required.
• 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 Excel, Word, SharePoint, clinical trial management systems and related software tools.
• Willingness to travel to investigative sites on a frequent basis (approximately 50%).

Travel Requirement:

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

What they offer:

• Industry competitive compensation
• Performance-base bonuses
• Stock options
• Employee Stock Purchase Plan
• 401K plan
• A collaborative and innovative work environment at the forefront of biotech advancements.
• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HSA
• Basic Life Insurance 2x Earnings & AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare systemUnlimited paid time off
• Remote work option
• Paid Holidays
• Health Days
• Winter shut-down
• Casual work environment

The anticipated salary range for candidates who will work remotely is $105,000 to $145,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.