Senior Clinical Research Associate
San Diego, CA
$130,000 - $150,000
We have a unique opportunity for a Senior Clinical Research Associate within a biopharmaceutical firm based in San Diego, CA. This firm is in the trial phases of developing groundbreaking pharmaceuticals aimed at treating incurable diseases by effectively silencing the genes responsible for them. Their innovative treatments leverage RNA interference (RNAi) mechanisms to achieve rapid, profound, and enduring suppression of target genes. Utilizing a range of RNA chemistries and efficient delivery methods, they harness the inherent power of RNAi, a cellular process that naturally inhibits the expression of individual genes, thus regulating the production of specific proteins.
As a Senior Clinical Research Associate (Sr. CRA), you will collaborate closely with the Clinical Operations Manager to oversee and monitor critical study outcomes. Your primary focus will be to assist the COM/Study Lead in the planning, execution, and closeout of the study, ensuring the fulfillment of deliverables and adherence to clinical protocols, study objectives, as well as ICH and GCP guidelines. This role primarily involves internal responsibilities.
- Support the Study Lead in fulfilling study requirements.
- Supervise crucial deliverables throughout study setup, maintenance, and closeout, including the generation, assessment, and distribution of internal tracking data at specified intervals (Site Status, Enrollment, Dosing).
- Collaborate with the Study Lead to develop or assess specific strategies or processes for study implementation.
- Compile and analyze relevant data from investigational sites
- Assist Clinical Trial Assistants (CTAs) with Trial Master File (TMF) setup, maintenance, ongoing quality assessment, and final reconciliation of research documents.
- Contribute to study-specific initiatives such as site activation and investigator identification.
- Play a role in the creation or review of monitoring plans related to the study, overseeing the scheduling and planning of site visits to ensure compliance.
- Participate in the development and evaluation of research materials, including case report forms (CRFs) and informed consent forms for clinical studies.
- Review monitoring visit reports and occasionally conduct co-monitoring visits with Contract Research Organizations (CROs) and Clinical Research Associates (CRAs).
- Assist in the development and modification of site reference documents (e.g., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log) as deemed necessary.
- Act as the primary point of contact for CRA/CTA inquiries regarding studies on behalf of CROs.
- Prepare and coordinate site qualification visits, site initiation visits, and site investigator meetings, as required, in collaboration with the CRO.
- Provide support to the Study Lead as needed in developing study-related materials for CRO staff training and in overseeing study suppliers (CRO, Drug Supply, Central Lab).
- Collaborate with clinical finance and the Study Lead to evaluate, track, and manage study-specific budgets.
- A bachelor's degree is preferred; however, applicants with a combination of relevant education and experience will also be considered.
- Three (3) or more years of experience in Clinical Research.
- Minimum of one (1) year of experience in site oversight and management.
- Proficiency in vendor oversight and management.
- Additional Perks:
- The company offers an excellent benefits package and a competitive salary.
- All applicants must be eligible to work for a US-based employer.
If you envision yourself as a Senior Clinical Research Associate and are interested in this opportunity, don't hesitate to submit your application promptly.