Aevi Genomic Medicine, Inc. is dedicated to translating genetic discoveries into novel therapies. Driven by a commitment to patients, and guided by genomic insights, we strive to help patients navigate through the complexities of their disease. If you are looking for an opportunity to be part of building a fast-paced, collaborative, scientifically-disciplined team, then this is a great time to join Aevi to make a difference in the lives of children and adults with pediatric-onset diseases.
Clinical Trials Liaison
|Title:||Clinical Trials Liaison|
|Department:||Research and Development|
Field-Based, ideally near a major airport
Field-based, the Clinical Trials Liaison will be engaged throughout the lifecycle of all Aevi Genomics clinical trials, providing scientific background, disease education, research rationale, protocol inclusion/exclusion criteria and pipeline support. This role will also be involved in the identification and evaluation of clinical trial sites; and will provide insight to study teams on best practices for the identification and recruitment of trial subjects.
Working with the clinical study teams, the Clinical Trial Liaison will provide general study support activities at the individual site level, including but not limited to the following:
- Aiding in establishing an effective strategy to recruit or identify potential subjects
- Communicating the scientific rationale for the study with site staff
- Discussing eligibility criteria and study procedures in detail with site staff
- Meeting with site staff (fellows, physician assistants, nurses, study coordinators etc) to maintain focus on overall design, rationale and eligibility criteria
- Conducting supplemental training as needed for complex study procedures
- Serving as primary contact for site personnel for protocol related questions/issues, and/or outside vendors and regional CRAs
- Participating in all types of study visits (pre-study, initiation, interim, and close-out) with clinical research associate, as needed
- Participating in departmental, clinical sub-team, and product development/strategy team meetings, as appropriate
- Conducting site visits as required
- Assisting in study-related training of regional monitors and site personnel as requested
- Responding to clinical sites in a timely fashion and maintaining appropriate documentation
- Serving as point of contact for the site regarding urgent study outcomes (local lab results, adverse events, etc) and disseminating information appropriately
- Supporting sites by facilitating IRB submissions and regulatory document collection and review.
- Strong written and verbal communication skills
- Able to understand and comply with Good Clinical Practices (GCPs) and internal SOPs
- Ability to Train Investigators and site staff on administration of investigational products
- A track record of success accelerating enrollment of patients through referrals and awareness initiatives
- Advanced degree required (Ph.D., PharmD, MS or equivalent); nursing or scientific background strongly preferred.
- Three or more years of clinical monitoring or relevant clinical trial experience
- Knowledge of the pharmaceutical industry, clinical research/trials, GCPs, ICH guidelines is required
- Proficient in Microsoft Office applications
- Ability to travel 80% or more
Aevi Genomic Medicine, Inc. offers its employees a competitive benefits and compensation plan.
Aevi Genomic Medicine, Inc. is an Equal Opportunity Employer.