Position: Clinical Research Associate
Function: Clinical Operations
Company: Phanes Therapeutics, Inc.
Location: San Diego, CA
Phanes Therapeutics is a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA this year: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). In addition, both PT886 and PT217 have received orphan drug designations from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.
At Phanes, we understand that scientific innovation is a challenging task and that’s why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent medical, dental and vision benefits, and excellent career growth opportunities.
This position is in the clinical operations function located at our office in San Diego, CA.
Summary: Under the supervision of the Clinical Operations Director, The Clinical Research Associate (CRA) is responsible for conducting all aspects of site monitoring for clinical research studies according to Phanes Standard Operating Procedures (SOPs) and ICH/GCP/GLP guidelines.
- Conducts pre-study (site qualification), initiation, interim monitoring and closeout visits
- Trains the study investigators and staff during the SIV and to trial-specific updates, all to industry standards
- Prepares site visit reports and sends confirmation/follow-up letters to sites per clinical monitoring plan
- Conducts and documents periodic telephone contact with sites in accordance with the Monitoring Plan
- Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy
- Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans
- Works with Data Management to ensure the query resolution process is followed and completed
- Identifies and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies
- Ensures site compliance to SAE reporting policy per protocol and with the Safety Management Plans
- Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the ADCM and CTM
- Assists the ADCM and CTM in the development and implementation of corrected actions for the addressing non-compliance issues at individual sites and across study, including timely follow-up to routine and for-cause Quality Assurance audits
- Work with investigators on their subject recruitment and screening strategies
- Tracks and reports progress of assigned sites, including subject screening/enrollment, data collection, adverse event documentation and Frequently Asked Questions document updates
- Partners with the in-house CTA(s) and/or CRAs in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF
- Assists with planning, preparing, distributing and presenting materials for Investigator Meetings and for study-related trainings
- Provides ongoing study-related training (i.e. EDC) and support to site staff as necessary
- Works with Clinical Team in the management of Investigational Product (IP) at clinical sites
- Manages inventory of clinical supplies at assigned sites and monitors the documentation of returns/destruction as appropriate
- May collaborate with the CTM and/or in-house CTA/CRA(s) on the development of certain study-specific plans and/or processes
- Ensure proper collection, storage and shipment of laboratory specimens
- Participates in Clinical Trial Team Meetings
- Bachelor’s Degree (BA/BS) in life sciences or nursing degree
- Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry or equivalent combination of education and experience
- Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3)
- Experience in oncology is highly preferred
- Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process
- Proficiency with MS Office
- Excellent oral and written communication skills including presentation skills
- Ability and willingness to travel to investigational sites for on-site monitoring visits
- Ability to perform virtual monitoring remotely as needed