Clinical Site Liaison

3 weeks ago

Boston, United States Mediar Therapeutics Full time
Job DescriptionJob DescriptionSalary:

Reporting to the Head of Clinical Operations, the Clinical Site Liaison (CSL) will serve as a field-based, site-facing resource and extension of Clinical Operations in support of assigned Mediar clinical development programs. The CSL will serve as an interface between Mediar, clinical study site personnel, and vendors to ensure quality and timely study execution at the site level.  The CSL will be responsible for cultivating and fostering long-term relationships with clinical trial investigators/study site personnel to help position Mediar as a Sponsor of choice. In addition, the CSL will support the effective CRO interactions with study sites by developing relationships with key CRO personnel and supporting the development of effective processes and communication between the CRO and Mediar as well as the CRO and investigator sites.

 

Responsibilities

Working proactively and in close collaboration with Mediar/CRO clinical study teams, the CSL will perform study activities, including but not limited to the following: 

  • Manage CRO partner to drive the Startup site activation timelines across all sites to the level of the individual site: Understanding critical path activities at the site level
  • Serve as the global start-up delivery expert, and oversee site activities from feasibility to regulatory green-light
  • Serve as Subject Matter Expert for site CTA, Budget, and Informed Consent documents and negotiations, triaging when necessary
  • Ensure site readiness activities are considered in the overall timelines for each site in partnership with CRO partner
  • Leverage all available intelligence to inform the Study Startup Strategy
  • Identify risks to site activation and develop mitigation plans, including providing input to SMT materials
  • Develop recruitment and retention initiatives; ensure full leveraging of recruitment and retention tactics by CROs and clinical sites
  • Monitor and track recruitment progress at study sites to ensure adherence with the site-specific recruitment plan
  • Identify and proactively mitigate challenges at study sites:
    • Strategically reviewing Protocols to ensure operational clarity for investigator sites;
    • Raise awareness of trends and issues with Study Management Team members related to site performance/adherence with study protocols
    • Collaborates with the Study Management Team to develop the baseline timelines and milestones
  • Engage study site personnel (i.e., Principal Investigator, Sub-Investigators, study coordinators, other HCPs, etc.) in discussions to:
    • maintain focus on overall study design, rationale, and eligibility criteria
    • identify operational hurdles/challenges and offer potential strategic solutions; apply mitigations broadly between sites and across studies
    • ensure quality execution of clinical studies
  • Participate in SIVs and attend other study visits with CRO CRA; may visit investigator sites without CRO personnel also
  • Help facilitate Investigator Meetings especially related to local considerations and relationship building with the site personnel and CRO
  • Collaborate and align with study MDs, Mediar cross-functional team members on clinical investigator engagement
  • Participate in Mediar and CRO meetings
  • Conduct and document Mediar monitoring oversight activities
  • Identify and develop needed internal procedures; delineate and communicate responsibility divisions across adjacent roles (i.e., CRO CRA, Mediar study lead); identify key performance indicators applicable to this role
  • Identify, communicate, and implement lessons learned across sites, regions, and studies

Qualifications

  • Bachelor’s Degree (health sciences or related field preferred)
  • AD: Minimum 8+ years clinical research experience in pharmaceutical or biotechnology field, with 6+ years of combined clinical monitoring and clinical operations study management experience in the biotech/pharmaceutical industry
  • Director: Minimum 10+ years clinical research experience in pharmaceutical or biotechnology field, with 8+ years of combined clinical monitoring and clinical operations study management experience in the biotech/pharmaceutical industry
  • Ability to develop robust knowledge of protocol, program goals, disease area, competitive landscape
  • Ability to convey scientific and medical information to a diverse audience; ability to translate clinical research objectives to strong and clear operational plans
  • Strong vendor management skills; experience developing/implementing processes and performance indicators
  • Strong written and verbal communication skills; effective collaboration, interpersonal and organizational skills
  • Ability to resolve issues independently but escalating, where necessary; mature stakeholder management skills
  • Relevant clinical experience and scientific degree/background
  • Knowledge of local and FDA regulatory requirements and ICH GCPs
  • Demonstrated skills in motivating and integrating project teams
  • Strong teaching and mentoring skills
  • Discerns relevancy of problems; explores options and arrives at solutions that correct situations
  • Able to set appropriate priorities for action, assess the effect of the decision, solution, or action accurately
  • Passion, humility, and excitement for doing whatever it takes to drive research forward toward a goal of helping patients with unmet medical needs



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