Clinical Operations Associate - San Diego, CA - Direct Hire
SRG is looking for a Clinical Operations Associate for a client of ours out of San Diego, CA. Reporting to the AD of Clinical Operations, you would be responsible for assisting the study team in running the day-to-day operational activities of clinical studies. You will have the opportunity to coordinate, track, & manage daily activities for multiple clinical studies to support the internal project team, vendors, stakeholders and the CROS.
- Demonstrate a clear understanding of FDA regulations, ICH Guidelines and Good Clinical Practice (GCP).
- Assists the study team in all aspects of the day-to-day operational activities of clinical studies. Coordinates, tracks, and manages daily activities for multiple clinical studies to support the internal project team, vendors, stakeholders and the CROs as applicable.
- Serve as a liaison and resource for investigational sites.
- Ensures that delegated components of clinical trials are executed in accordance with specified Standard Operating Procedures (SOP) and within timelines.
- Under the guidance and direction of clinical operations team, the COA interfaces with R&D functions to coordinate relevant and timely exchange of information / materials to support clinical operations deliverables within the drug development process.
- Works directly with clinical operations and study team to optimize and implement clinical studies according to GCPs and relevant SOPs.
- Receive, review, and assess study documents required for site activation and investigational product release.
- Maintain metrics on results of study documentation reviews.
- Create and ship investigator site binders to investigator sites.
- Assist with IRB submissions and IRB correspondence. Ensure all documents are added to the TMF with appropriated naming conventions.
- Supports internal clinical operations in monitoring the implementation and progress of a clinical study.
- Develops and maintains relationships with external vendors.
- Manage and update study contact lists E.g. Vendor Contact list
- Collaborates with consultants and contractors as directed by a Clinical Operation study team member.
- Works closely with Clinical Operations in coordinating, tracking, and managing logistics in support of clinical trials.
- Responsible for reconciliation of vendor invoices/PO management, as well as vendor and contractor payments.
- Tracks study status, enrollment, EDP review, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of investigational product.
- Responsible for set-up, maintenance, reconciliation and archiving of Trial Master Files (TMF) along with internal working files; coordinates TMF transfer with CROs.
- Assists with TMF oversight review as required for quality, accuracy and completeness.
- Interacts with CROs, vendors, investigators, monitors, and other external partners to provide information and resolution for specific study requests and issues.
- Responsible for document management in electronic database systems.
- Coordinates project meetings, including scheduling, preparation of meeting materials, drafting and distribution of meeting agendas and minutes.
- Supports the development and implementation of Standard Operating Procedures (SOPs) and common work practices within the team.
- Actively participates in the development of department initiatives; contributes ideas on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.
- Identify gaps in operational processes to ensure compliance in applicable SOPs in the achievement of study milestones, data quality, and data integrity.
- Bachelor’s degree, or equivalent, in a biomedical, life science, or related field of study. Equivalent combination of education and applicable job experience may be considered.
- Minimum three (3) years of related experience; clinical operations experience in a pharmaceutical or CRO setting preferred.
- Understanding of FDA regulations, GCPs and ICH guidelines is a must.
- Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
- Good problem-solving skills, and a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
- Intermediate proficiency in the Microsoft Suite required.
- Knowledge of Access, Visio, or similar database a plus.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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