Clinical Trial Liaison | 12 Month Engagement
Are you a dynamic Clinical Trial Liaison with a passion for fostering exceptional site relationships and driving clinical trial success? We're supporting a leading biotech company as they expand their Clinical Operations team in preparation for a pivotal Phase 3 launch later this year. Are you dedicated to providing unparalleled support to investigative sites and thrive in a fast-paced evolving environment?
If so, we'd love to hear from you!
Non-Negotiables
- Must be West Coast-based (e.g., CA, OR, WA).
- Willing to travel 50-75% domestically
- Must live in close proximity to a major airport
- Demonstrated Customer-Centric Focus: commitment to providing outstanding service and support to investigative sites and staff.
- Full-time salaried position with full benefits including PTO
location: South San Francisco, California
job type: Contract
salary: $70 - 80 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
What You'll Do:
The Clinical Trial Liaison will be instrumental in ensuring successful trial delivery and performance across assigned regions. Your responsibilities will include:
- Driving site performance, data capture, and data quality.
- Providing direct training and ongoing support to CRO CRAs and local site staff.
- Motivating local teams and acting as a company ambassador to foster strong partnerships.
- Overseeing CRO monitoring activities to ensure compliance and adherence to study processes.
- Conducting co-monitoring and study progress visits to assigned trial sites.
- In conjunction with Investigators and other key stakeholders at sites (e.g., study coordinator, business manager, nurse, pharmacist), facilitating collaboration between different departments or groups within the same trial site to optimize the enrollment of trial subjects.
- Working across trials in the same or similar therapeutic areas within the assigned region.
- Advising on suitable trial sites within the region and participating with the CRO in feasibility and site selection activities as appropriate.
- Supporting the CRO in optimizing local start-up activities and timelines.
- Supporting the development of recruitment and retention plans, leading on any bespoke local requirements.
- Providing training and re-training to CRO CRAs and site staff (supporting the CRA) as needed.
- Reporting on the local situation at the site, including opinions and observations related to the operational, scientific, and any other aspects of the trial.
- Feeding information up to the Project Manager on site performance and risk.
- Collaborating with other CTLs and the wider study team, as appropriate, to share beneficial experiences and best practices via regular CTL team meetings.
- Facilitating the resolution of challenges that the sites are facing, such as recruitment issues and quality issues, which are tailored specifically to the local situation.
- Resolving issues primarily independently but also appropriately escalating issues where necessary.
- Working with QA, assisting with audit and inspection preparations and follow-up, including the generation and implementation of CAPA plans. Attending site audit close-out meetings.
- Supporting the CRO in site budget negotiations as necessary.
- May be asked by the Project Manager to check/verify local invoiced costs.
- May have supervisory responsibilities of CRAs and/or CTL colleagues.
- Attending all Team Meetings (internal and external) that pertain to the assigned studies.
- Providing documentation and metrics for site visits and site communications.
qualifications:
- Education: Minimum B.A./B.S. degree in science/healthcare field required.
- Experience: Minimum 5 years of experience in a relevant clinical research role at a biotechnology or pharmaceutical company.
- Clinical Trial Process: Solid understanding of the clinical trial process.
- GCP & Regulatory: Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical development phases.
- Problem-Solving: Ability to develop innovative solutions to complex problems.
- Leadership & Adaptability: Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflict resolution, and effective partnership.
- Independent & Proactive: Strong ability to work and problem-solve independently with little guidance/supervision and a proactive approach.
- Customer Expectation Management: Demonstrates internal and external customer expectation management and alignment.
- Commitment to Excellence: Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives.
- Prioritization: Ability to prioritize workload to meet multiple project timelines.
- Compliance Standards: Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) guidelines.
- Communication: Excellent verbal and written communication skills. Ability to explain methodology and consequences of decisions in lay terms.
- Interpersonal Skills: Excellent interpersonal skills, adaptability to changes, conflict resolution, and effective partnership.
- Diabetes or Obesity is a plus, however candidates with a strong clinical background and solid Clinical Trial Liaison experience is the primary focus along with the ability to provide exceptional site and investigator support, ensuring our partners feel highly valued and supported.
skills: Site Initiation, Site Management, ICH Regulations, Patient Enrollment, Site Selection, Site Feasibility Assessment, Site Activation, Patient Retention Strategies, Site Monitoring, Good Clinical Practice (GCP), Site Engagement, Training
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
