Clinical Research Associate

Job Title: Clinical Research Associate

Location: Palo Alto CA 94304

Duration: 2 Months

Hybrid: 9am-5pm with some flexibility

Core Duties:

45********: Collect and manage patient and laboratory data for clinical research projects. Manage research project databases develop flow sheets and other study related documents and complete study documents/case report forms.

• The POETIC RDMC Clinical Research Associate (CRA) participates in early-phase sponsor and investigator-initiated clinical trials across approximately 15-30 sites in the US and Canada focusing on Pediatric Oncology including neuro-oncology hematology oncology and solid tumors. Some studies are sponsored by pharmaceutical companies while others are investigator-initiated trials funded through philanthropic grants.
• The CRA leverages expertise in interventional trial conduct and regulatory requirements collaborating directly with the POETIC RDMC clinical research regulatory and data management teams to ensure compliance with protocol procedures.
• The CRA coordinates study compliance data collection abstraction entry and reporting and apply their judgment to establish best practices for timely data collection and document all study-related communications and progress. The CRA inspects source documents and case report forms for both investigator- and sponsor-initiated trials. They review the study data entered by clinical sites and initiate queries to address database needs including query resolution missing data data entry timelines and data locks.
• The CRA adheres to the protocol and collaborates with the POETIC RDMC team to ensure compliance. They monitor all data entered by participating sites for investigator- initiated trials initiate queries and work with the sites until resolution. When necessary the CRA notifies the POETIC RDMC Data Specialist and Regulatory Manager and/or the site of deviations missing data unresolved queries or lost-to-follow-up cases ensuring that patient data is audit- ready.
• The CRA assists sites with any operational questions regarding electronic database systems until resolution. They proficiently use research databases (e.g. Medidata Rave Redcap Cloud Access Excel Case Report Forms) to complete assigned tasks or assist research staff. Additionally the CRA may support the Clinical Research Specialist Data Specialist and Clinical Regulatory Manager with monitoring IRB and FDA document preparations as needed.

30%: Assemble study kits for study visits monitor scheduling of procedures and charges coordinate documents and attend monitoring meetings with sponsors acting as primary contact.

• For the POETIC IITs the CRA manages in collaborating with another team member the study research kits which involves overseeing inventory
• orders assembling kits shipping them to sites and tracking samples from the sites to the labs.
• The CRA will work with the sites research staff to ensure the research kits have arrived if were collected when a patient is on study and sent to the lab processed and stored.

20%: Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.

• The CRA under the supervision of the POETIC RDMC Regulatory Manager is responsible for filing essential regulatory documents such as CVs medical licenses (MLs) and CITI training certificates in the designated Trial Master File (TMF) locations.
• Additionally the CRA ensures that these documents are accurately recorded in the Table of Contents (TOC) for efficient tracking and compliance.

5%: Participate in monitor visits and regulatory audits.

• When a site monitoring visit occurs and in the case of POETIC being audited the CRA will assist in preparing for the audit visit with POETIC team and representatives as
• needed.

Desired Qualifications:

• Bachelor s degree in related medical field.
• Experience working with oncology clinical research studies.
• 1-2 years of experience in a clinical research setting is highly desirable.

Knowledge skills and abilities (required):

• Strong interpersonal skills.
• Experience in clinical research with a preference for expertise in oncology pediatric oncology and early-phase studies
• Knowledge of medical terminology.
• Proficiency with Microsoft Office Outlook Box etc.
• Ability to quickly assimilate new information and adapt to changing environments.
• Proven ability to make meaningful contributions from the very beginning.

Certifications & licenses:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.