Why Seres Therapeutics
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.OurSER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.
Seres Therapeutics is a member of the Flagship Pioneering family of companies.
Partnering with Clinical Trial Managers, the Clinical Research Liaison is responsible for overseeing CRO monitoring performance, site performance and relationships, study recruitment, development and execution to study plans. The Clinical Research Liaison (CRL) may be assigned to multiple studies across the Seres portfolio.
What You'll Do
- In alignment with Seres SOPs and Clinical Oversight Plans, the CRL will conduct oversight visits which may be combination of onsite and remote.
- In alignment with SERES SOPs and Clinical Oversight plan, review monitoring trip reports to extend additional Sponsor support to site staff for recruitment, vendor support, and to assess the quality of CRO monitoring activities and documentation throughout study conduct.
- The CRL will be responsible for developing and maintaining the CRL visit and monitoring report strategy as well as documentation of visits/reports. CRL will perform compliance checks against the CRL visit and monitoring visit strategy for Seres reviews
- Perform review of CRO's compliance with monitoring plan (scheduling, report delivery, issue escalation etc)
- Will lead Monitoring Meetings with CRO at intervals determined
- In accordance to Seres SOPs and Clinical Oversight Plan, perform and document required Seres oversight/approval for site feasibility, site selection visits, site initiation visits, interim monitoring visits and close out visits. In compliance with SOPs, review, track and present metrics for monitoring trip report review as part of CRL oversight to identify study trends and escalate any study risks.
- Develop and maintain relationships with clinical investigators, clinical research organizations (CRO) and research institutions to initiate and expedite clinical studies for investigational new drugs, by way of phone calls, site visits, email blasts, other supportive activities
- Review and contribute to Monitoring Plan and related CRO monitoring documentation
- With CTA, is responsible for ensuring that active clinical site lists are up to date and submitted to regulatory as required for IND updates
- Supports Clinical Trial Manager (CTM) with eTMF annual QCs, with focus on site files and CRO study plans
- Work closely with CROs, sites and site personnel to develop study and/or site patient recruitment and retention tactics and strategies appropriate to the individual study needs and generate/monitor enrollment modeling scenarios and continuously evaluate the recruitment projections for improvements or triggers to support the implementation of action and/or contingency planning. Oversee CROS and CRAs in execution and progress of program and site recruitment plans.
- With CTM and Data Management, responsible for overseeing CRO and CRA team's data cleaning progress in advance of interim or final database locks
- Participate and contribute to risk review activities with cross functional study team and CRO partner
- With CTM, CRL is responsible for approval of CRA resources proposed by CRO, in compliance with study plans and Seres SOPs, as well as final documentation of said approval via Key Personnel approval forms.
- With CTM, CRL is responsible for site selection documentation per study plans and Seres SOPs.
- Work with CRO personnel (CRAs, CTMs, PM's) to ensure proper study conduct, review trends and help develop mitigations for implementation.
- CRL will participate in the following CRO oversight activities:
- frequent review of protocol deviations for trend analysis to suggest additional training needs or study considerations;
- CRO reported site quality issues, data quality review, and IXRS reporting for IP compliance/management.
- Ensure that CRO quality issues trackers include site issues
- Monitor progress of clinical trials at the site level and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
- Contribute to development and review of study manuals, study plans, site facing documents, webinar/training content.
- Contribute to development and implementation of social media in support of recruitment for Seres clinical trials.
- Actively engage and manage Seres relationships with patient advocacy groups, key sites and staff.
- Escalate site/monitoring related quality issues to SERES QA. Partner with SERES QA in development and completion of QIs and/or CAPAs, where needed.
- Writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals.
- Mentor and provide onboarding training for new clinical research liaisons, CRAS, CTAS. May have management responsibilities for clinical trial staff.
What You'll Bring
- A minimum of 3 years experience in monitoring, as a Clinical Research Associate or performing data review
- Proven ability to work with cross functional teams, study vendors and clinical trial sites.
- Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally
- Knowledge - thorough understanding of GCP/regulatory requirements
- Proactiveness - the ability to identify challenges and risks and implement appropriate actions with some supervision
- Motivation - highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
- Collaboration - to coordinate activities of internal cross-functional study team as well as external vendors as applicable
- Open-mindedness - listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions
Candidates should be aware that Seres Therapeutics currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date.
Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.