Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.
We don’t follow footsteps. We create the path.
Summary
The clinical trial liaison (CTL) is a specialized, field-based role exclusively focused on engaging investigative sites participating in clinical trials. The CTL serves as the consistent face of Spark and point of contact for a clinical trial or program and is responsible for providing support for clinical trial management. S/he coordinates communication between sites and the Sponsor/CRO and provides 1:1 support to each site as needed. The clinical trial liaison works with all the sites on the trial to ensure that all investigators and study staff continue to be fully engaged throughout the course of the trial.
Responsibilities
In conjunction with the clinical study team for assigned projects, the CTL will provide general study support activities at the individual site level, including but not limited to the following:
• Aid in establishing an effective strategy to recruit or identify potential subjects
• Communicate the scientific rationale for the study with site staff
• Discuss eligibility criteria and study procedures in detail with Principal Investigator (PI) and site staff
• Meet with site staff (fellows, physician assistants, nurses, study coordinators etc) to maintain focus on overall design, rationale and eligibility criteria
• Conduct supplemental training as needed for complex study procedures
• Serve as primary contact for site personnel for protocol related questions/issues, and/or outside vendors and regional CRAs
• Participates in all types of study visits (pre-study, initiation, interim, and close-out) with clinical research associate, as needed
• Participates in departmental, clinical subteam, and product development/strategy team meetings, as appropriate
• Conducts site visits as required
• Assist in study-related training of regional monitors and site personnel as requested
• Respond to clinical sites in a timely fashion and maintain appropriate documentation
• Serve as Sponsor point of contact for the site regarding urgent study outcomes (local lab results, adverse events, etc) and disseminate appropriately
• Participate in departmental initiatives, as requested
• Support sites by facilitating IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with the study lead and Legal.
• Be proactive in site support activities
Qualifications
• Strong written and verbal communication skills
• Available to meet peak workload demands and critical timelines; organized and efficient
• Highly attentive to detail; able to deliver a high-quality work product
• Able to understand and comply with Good Clinical Practices (GCPs) and internal SOPs
Requirements
• Advanced degree required (Ph.D., PharmD, MS or equivalent) with 3 years experience; nursing or scientific background strongly preferred. Bachelor’s degree with 7 years of relevant experience may be considered
• Minimum of three years of clinical monitoring or relevant clinical trial experience
• Experience in therapeutic area of interest to Spark (eg, ophthalmology, hematology, immunology, neurology) is required
• Knowledge of the pharmaceutical industry, clinical research/trials, GCPs, ICH guidelines is required
• Knowledge of Key Opinion Leaders in therapeutic area
• Proficient in Microsoft Office applications
To Apply to this Job, Please go to the website address given in the source.
Source: https://www.jobserve.com/us/en/search-jobs-in-Philadelphia,-Pennsylvania,-USA/CLINICAL-TRIAL-LIAISON-05FB0E9F1DD13460/?utm_source=50&utm_medium=job&utm_content=1&utm_campaign=JobSearchLanding
