Clinical Research Specialist
Proclinical is currently recruiting for a Clinical Research Specialist with a pharmaceutical company located in Irvine, CA.
- Serve as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones
- Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
- May serve as the primary contact for clinical trial sites (e.g. site management)
- Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials
- Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
- Oversee the development and execution of Investigator agreements and trial payments
- Responsible for clinical data review to prepare data for statistical analyses and publications
- If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
- May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
- Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
- Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
- Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Support project/study budget activities as assigned
- Develop a strong understanding of the pipeline, product portfolio and business needs
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Skills and Requirements:
- Minimum of a bachelor's degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
- 4 years of clinical research study support experience required
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
- Medical device experience highly preferred
- Neurovascular clinical trial experience preferred
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.