Clinical Research Associate
Location: Emeryville, CA
Department: Clinical Development - Fintepla
The Clinical Research Associate (CRA) provides support to cross-functional teams in the planning, start-up, maintenance and closeout of study activities conducted within the Clinical Operations Department, in compliance with the protocol, Good Clinical Practice (GCP) and applicable regulations and in accordance with Zogenix Standard Operating Procedures.
- Assists in preparation of clinical study documentation such as study protocols, Informed Consent Forms (ICFs), study-specific plans, manuals, Case Report Forms (CRFs), Study Master File Index (SMFI) and training materials.
- Supports identification, requirements and evaluation of clinical study sites.
- Effectively oversees site initiation, activation, patient enrollment, monitoring and close-out activities for multiple clinical studies.
- Ensures clinical study documentation is filed, complete and maintained.
- Oversees and participates in audit readiness activities.
- Oversees monitoring activities of monitors; co-monitors as required.
- Develops and tracks monitoring metrics to evaluate monitoring and site performance.
- Provide study progress updates to CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Develop study plans and participate in system set-up (e.g. UAT of EDC, IRT).
- Identifies, evaluates and properly captures Adverse Events. Ensures adequate follow up, timely documentation and reporting according to internal procedures and regulatory requirements.
- Supports clinical safety event process by coordinating adjudication body activities (DSMC, CEC, SMC or other adjudication body designated by the study protocol).
- Contributes to preparation of clinical study reports.
- Monitors study status and risks; identifies the need for, escalates, informs and implements corrective and preventative actions.
- Supports testing and training study team on clinical study systems such as electronic data capture (EDC) or electronic trial master file (eTMF) systems.
- Establishes appropriate communication processes and support interactions with clinical study vendors and external research organizations such as CROs and central laboratory.
- Under the oversight of Senior Clinical Trial manager, facilitates site agreements and budget negotiations.
- Other duties as assigned
- Strong attention to detail
- Highly accountable
- Team player who enjoys interaction with different functions
- Manages ambiguity
- Action oriented
- Communicates Effectively
- Bachelor’s degree in a health sciences field preferred
- 4+ years’ experience in Clinical Operations (or equivalent)
- Sound understanding of GCP and other applicable guidelines/regulations
- Strong understanding of Clinical Operations
- Able to set priorities and juggle multiple demands.
- Able to work independently while exercising initiative, flexibility and sound judgment.
- Proficient in software applications such as Word, Excel and PowerPoint
- Good written and verbal communication skills
- Strong organizational skills with attention to detail
- Good problem-solving and analytical skills
- Experienced in working with and processing document in TMF
- Experience in working with common Clinical Operations systems (EDC, IWRS, vendor portals, etc.)
- Some project management experience preferred
- Lead and/or participated in process improvement/efficiency initiatives
- Excellent written and verbal communication skills
- Possess excellent interpersonal skills
- Proficiency with MS Word, Excel, Outlook, Project and PowerPoint
- Demonstrated creativity and innovation to support projects and initiatives
- Attention to detail
Special Working Conditions
- Ability to travel as required