Psychometric Rater/Site Research Manager
4 weeks ago
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.
Must be located in the Eastern Time Zone
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:
\t- Oversee and monitor clinical trial activities at investigative sites, ensuring compliance with protocols, regulatory requirements (GCP and ICH), and company standards.
\t - 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.
\t - Perform site troubleshooting and issue spotting, proactively identifying and resolving challenges to ensure the smooth progress of clinical trials.
\t - Collaborate with cross-functional teams internally to address site-related issues and implement effective solutions.
Site Engagement and Relationship Building:
\t- Build and maintain strong relationships with investigators, site staff, and key stakeholders to foster a collaborative and supportive environment.
\t - 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:
\t- Review and verify clinical trial data, ensuring accuracy and completeness in accordance with protocols and regulatory standards.
\t - Perform clinical quality review of data and source documents to ensure internal consistency of data and concordance with expected clinical profiles across data sources.
\t - Data literacy, including analyzing, interpreting, and questioning data. Develop analytical reports to identify patterns and trends at the subject, site and study level.
\t - Conduct reviews of clinical charts (paper and electronic), source documents, and case report forms.
\t - Assist in development of monitoring tools for use by CRO and other team members.
\t - Prepare regular reports on site performance, patient recruitment, and other relevant metrics, providing updates to internal teams and stakeholders.
Regulatory Compliance and Documentation:
\t- Build and maintain strong relationships with key internal and external stakeholders, including investigators, Key Opinion Leaders (KOL), CROs, and regulatory agencies.
\t - Stay updated on relevant regulations, guidelines, and best practices related to clinical research and ensure site compliance with these standards.
\t - Assist in the preparation of regulatory submissions and documentation, collaborating with regulatory affairs teams as necessary.
Continuous Improvement and Process Optimization:
\t- Identify opportunities for process optimization and improvement in clinical trial conduct, site engagement, and monitoring activities.
\t - Contribute to the development and implementation of best practices and standard operating procedures to enhance the efficiency and quality of clinical research operations.
QUALIFICATIONS:
\t- Master's degree in related field, may be substituted with experience.
\t - Minimum of 5 years of experience in clinical research, with a strong preference for Psychiatry background, preferably in a biotech or pharmaceutical setting.
\t - Psychometric rater experience required.
\t - Strong understanding of GCP (Good Clinical Practice) guidelines, regulatory requirements, and industry standards. CCRC and GCP current certification a strong plus.
\t - Excellent communication and interpersonal skills, with the ability to build rapport and maintain positive relationships with diverse stakeholders.
\t - Detail-oriented, analytical, and proactive, with the ability to identify issues and implement effective solutions.
\t - Proficiency in using Excel, Word, SharePoint, clinical trial management systems and related software tools.
\t - Willingness to travel to investigative sites on a frequent basis (approximately 50%).
Travel Requirement:
\t- 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:
\t- Industry competitive compensation
\t - Performance-base bonuses
\t - Stock options
\t - Employee Stock Purchase Plan
\t - 401K plan
\t - A collaborative and innovative work environment at the forefront of biotech advancements.
\t - Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
\t - FSA and HSA
\t - Basic Life Insurance 2x Earnings & AD&D
\t - Employee Assistance Program
\t - Healthcare advocates group to help navigate the healthcare systemUnlimited paid time off
\t - Remote work option
\t - Paid Holidays
\t - Health Days
\t - Winter shut-down
\t - 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.
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\tSeniority Level
\tMid-Senior level
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\tIndustry
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\t\t- Biotechnology Research
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\tEmployment Type
\tFull-time
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\tJob Functions
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\t\t- Research
\t\t - Management
\t\t - Science
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\tSkills
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\t\t- Clinical Trial Management System (CTMS)
\t\t - Key Opinion Leaders
\t\t - CRO Management
\t\t - Google Cloud Platform (GCP)
\t\t - Good Clinical Practice (GCP)
\t\t - Clinical Trials
\t\t - SharePoint
\t\t - Trial Management
\t\t - Industry standards
\t\t - Clinical
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\t\t\t\tAs part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.\t\t\t
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About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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