Senior CRA in Fremont, CA at Stryker Corporation

Date Posted: 7/26/2018

Job Snapshot

Job Description

The Senior Clinical Research Associate (Sr. CRA) demonstrates an ability to independently manage clinical trials by independently supporting the planning, preparation, execution, control/monitoring and closeout of clinical trials. The SR. CRA establishes cross-functional and KOL relationships, monitors and/or supervises the monitoring activities of assigned clinical trials to ensure data integrity and adherence to Federal regulations, company policies, and any other applicable procedures. Responsible for supporting compliance with applicable Regulations, ICH/GCP principles, Stryker SOPs, and timely completion of complex global neurovascular studies.

Essential duties and responsibilities include:

The Sr. CRA is responsible for independently conducting the following essential duties:

Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements;

  • Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
  • Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);
  • Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);
  • Verify Investigational Product accountability;
  • Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);
  • Conduct routine monitoring visits on behalf of the clinical trial sponsor.
  • Prepare manual of operations for study sites
  • Prepare informed consent documents 
  • Completes clinical project deliverables per schedule
  • Ensures audit-readiness
  • Communicates relevant information to the PM/LCRA in a timely manner
  • Contacts sites on a consistent basis to assess study compliance
  • Identify and address noncompliance issues at investigative sites, assist Sr. CRA with CAPA, if necessary
  • Tracks Screening & Enrollment and identify issues and propose solutions.
  • Independently confirms that site documents match Study Master File
  • Participates in the conduct and training at Investigator Meetings.
  • Maintains expertise in regulations for all geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
  • Generates status reports, oversees process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.
  • Collects and tracks regulatory documents (e.g., confidentiality disclosures, IRB approvals, investigator agreements, contracts, study/project annual reports and financial disclosures) to/from study sites using company specific database
  • Reviews and collects documents to compile  Clinical Events Committee (CEC) packets for CEC adjudication meetings
  • Assembles and tracks metrics data.
  • Mentors and trains CTCs
  • Recommends process improvements to increase team efficiencies and effectiveness.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements Complete all training requirements on time
  • Potential exposure to blood borne pathogens and other potentially infectious materials.
  • Plans owns work assignments;  may plan and/or delegate work to others

Work From Home: No

Travel Percentage: Up to 50%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team