Senior Clinical Research Associate – Central/West Coast

Job Description

Conducting site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) to ensure compliance with regulations, ICH-GCP, GPP, and the study protocol. Using expertise to assess site performance and recommend actions. Immediately communicating critical issues to the project team and creating action plans. Maintaining knowledge of ICH/GCP guidelines, regulations, and company procedures. Verifying informed consent processes and documentation for each participant. Protecting the confidentiality of all participants. Assessing factors affecting participant safety and data integrity, such as protocol deviations and pharmacovigilance issues. Evaluating site processes according to the CMP/SMP. Performing source document review of site records. Ensuring CRF data accuracy via source document review. Applying query resolution techniques, both on-site and remotely, and guiding site staff to resolve issues within established timelines. Using hardware and software to support data review and capture. Confirming site compliance with electronic data capture requirements. Performing investigational product (IP) inventory, reconciliation, and storage reviews. Verifying IP dispensing and administration according to the protocol. Identifying risks related to IP blinding or randomization. Applying GCP knowledge to ensure proper IP labeling, import, and release/return. Reviewing the ISF for accuracy and completeness. Reconciling ISF contents with the TMF. Ensuring site awareness of archiving requirements. Documenting activities through letters, reports, and communication logs. Supporting participant recruitment, retention, and awareness. Entering data into tracking systems. Understanding project scope, budgets, and timelines. Adapting to changing priorities. Acting as a liaison with site personnel. Ensuring site team training and compliance. Preparing for and attending meetings. Participating in clinical monitoring meetings. Providing guidance for audit readiness and support follow-up actions. Offering training and mentorship to junior CRAs. Conducting training and sign-off visits for junior staff.

Qualifications

1. Bachelor’s degree or RN in a related field or equivalent experience. 2. Knowledge of Good Clinical Practice/ICH Guidelines and other regulations. 3. Proficient computer skills and ability to adapt to new technologies. 4. Excellent communication and interpersonal skills. 5. Strong critical thinking abilities. 6. Ability to travel up to 75% regularly.

Benefits

- Health benefits including Medical, Dental, and Vision. - Company match 401k. - Eligibility to participate in the Employee Stock Purchase Plan. - Flexible paid time off (PTO) and sick time.