Clinical Research Associate I

At InterVenn, we believe no one should be blindsided by disease. Our technology enables and empowers the understanding of Glycoproteomics, a new clinical layer of biology beyond the genome, using a simple blood draw. InterVenn’s powerful solutions will broaden humankinds’ perception and interpretation of diseases like cancer. We look forward to having new members join our team who have diverse perspectives and backgrounds, challenge the status quo, and are solution oriented. If this is you, read-on and apply. Together, maybe we can change the world.

InterVenn is seeking talented, experienced, and self-driven Clinical Research Associate to join our highly collaborative and supportive team. This position can be located onsite in our South San Francisco office or performed remotely from the US Pacific or Mountain time zones.

RESPONSIBILITIES

• Maintain up to date training and education on InterVenn product(s), including a basic understanding of the underlying science
• Maintain up to date training and compliance with relevant InterVenn SOPs as well as regulations associated with clinical research and laboratory requirements (e.g., 21 CRF 812, 50, 54, 56, ICH/GCP, CLIA/CAP, ISO, etc.)
• Collect essential documents from sites and set-up Regulatory files and assist with maintenance of the Trial Master File (TMF)
• Coordinate, conduct and document study specific training at research sites
• Coordinate and conduct onsite and/or remote site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visit (IMVS) and/or close-out monitoring visits (COVs) in accordance with SOPs and study specific procedures
• Develop and complete reports documenting outcome of site visits, escalating concerns as needed to Clinical Operations & Patient Affairs Management Team and Chief Scientific and Medical Officer, as needed.
• Manage lab kit inventory and fulfill orders as needed for study sites
• Provide and/or support training and expertise on clinical aspects of the protocol in collaboration with Clinical Operations & Patients Affairs and Medical and Scientific teams.
• Assist in development of study protocols, ICFs and other study related documents in coordination with internal and external teams
• Assist with site selection process
• Assist with submissions to central and/or local IRBs
• Assist with development of clinical trial recruitment materials
• Assist with site contract development and budget negotiation with support of InterVenn Legal and Clinical Operations & Patient Affairs Management Team
• Liaise on an ongoing basis with investigators, study coordinators, regulatory personnel and other key site team members conducting the trial
• Other duties as assigned

QUALIFICATIONS

• Undergraduate degree, in health-related field
• RN/BSN preferred
• Therapeutic experience in oncology preferred
• 2-5 years of experience as a Clinical Research Associate (CRA) within a Sponsor or CRO
• Ability to work within Pacific or Mountain time zone, and participate in teleconferences that may fall outside of regular business hours to allow for collaboration between the global organization
• Demonstrated excellence in communication to a diverse audience including both experts and lay personnel.
• Demonstrated excellence in customer (internal and external) relationship skills
• Demonstrated excellence in organizational and writing skills, including exceptional attention to detail
• Willingness and ability to work with a team as well as independently
• Willingness and ability to travel domestically up to 50% with the possibility of an increased percentage during study start-up and close-out.
• A genuine desire to impact patient lives
• Ability to provide appropriate vaccination records to allow on-site access to research sites

Ensuring a diverse and inclusive workplace where we learn from each other is core to InterVenn’s values. We welcome people of different backgrounds, experiences, abilities, and perspectives. We are an equal opportunity employer and a fun place to work. Come do the best work of your life here at InterVenn.