Job Description
Serving as a value-added resource the Clinical Trial Liaison (CTL) will support the RTP904 Clinical Development program in the United States, Canada, or Australia, or other territories as assigned. The CTL will serve as a liaison between the RAPT in-house Study Execution Team (SET), the clinical study sites and other research team personnel and will be responsible for identifying and conducting outreach to clinical investigators and site staff to develop relationships, support education and enrollment issues and identify, analyze, and resolve issues with clinical research sites and investigators.
This position will support in the areas of compliance, regulatory affairs and study specific training. Documentation of all external site interactions will be expected.
Major Duties And Responsibilities - Identify and conduct outreach to clinical investigators, site staff and referring physicians to develop relationships and support enrollment initiatives.
- Engage site staff and investigators in discussion to understand and report challenges in subject enrollment and retention and offer potential solutions.
- Educate clinical trial sites and referring physicians about clinical trial protocol, disease state or study design as required.
- Interact and build positive relationships with key stakeholders at the clinical sites and on the RAPT SET. Key stakeholders may include clinical investigators, study coordinators, RAPT SET Lead and Clinical Trial Managers, select Clinical Research Associates (CRAs) and other CRO staff.
- Participate in Clinical Study Team meetings and Quality Review meetings where necessary providing input to study teams on operational issues based on site visits and contacts.
- Communicate investigator/study coordinator inquiries requiring follow-up to designated contacts within the SET.
- As requested, attend and present at investigator meetings, CRA workshops/training.
- Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative.
- Complete all administrative responsibilities consistent with SOPs and departmental guidelines including but not limited to required training, field activity documentation, expense reporting, and other assigned tasks.
- Assist study team members performing site identification, qualification, selection, initiation, monitoring, management, and close out visits as needed.
Education Requirements - Healthcare/science background with a PharmD, PhD and MD (or equivalent) desired.
- Bachelor’s degree or equivalent in a scientific discipline required.
Experience Requirements - Significant relevant clinical trial experience.
- Inflammatory disease specialty desired, with experience in chronic spontaneous urticaria and/or food allergy highly preferred.
- 4+ years of clinical research experience within academic, healthcare system or industry setting (e.g., clinical research coordinator, research manager, CRA, study coordinator, research director). Qualified individuals will have a strong familiarity or and experience with clinical research and study site logistics.
- Prior pharmaceutical industry experience as a Medical Science Liaison or Clinical Trial Liaison highly regarded. Candidates should have a solid understanding of scientific exchange in the context of a compliance landscape.
- Ability to identify and support resolution of study and enrollment challenges. Able to interact with site PI and staff in a supportive manner.
- Established track record of effective and influential oral presentations within the healthcare profession.
- Experience presenting to both large and small audiences is required for success in this position.
- Excellent oral and written communication skills and interpersonal skills.
- Exceptional organizational and time management skills are essential.
- Knowledge of ICH GCP compliance and regulatory requirements.
- Ability to integrate and work in cross functional network.
- Ability to manage assigned territory from a home-based office.
- Willingness to travel required; overnight travel is required as needed.
- Demonstrated project management ability.
- Computer skills including Excel, Word, Power Point, Outlook, Project and Adobe Acrobat are expected.
- Level (Sr CTL vs CTL) will be commensurate with the experience of the successful candidate.
Other Qualifications - Willingness and ability to travel to our South San Francisco office as requested.
California law requires pay information in job postings.
The specific rate will depend on the successful
Candidate’s Qualifications, Prior Experience, And Other relevant factors. The estimated annual pay range for this
position is
$165,000 (entry-level qualifications) to $198,300 (highly
experienced).
Job Tags
Work at office, Work from home, Night shift,