Clinical Research Specialist

This Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:

• Serves 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, under supervision;

• Participates in the 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);

• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);

• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;

• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Interfaces and collaborates with Clinical Research Associates (CRAs);

• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;

• Assists in clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Assists in tracking assigned project budgets;

• May perform other duties assigned as needed;

• Is 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;

• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

• Previous experience in clinical research or equivalent is desired.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Clinical/medical background is a plus.

• Medical device experience is a plus.

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;

• Presentation and technical writing skills;

• Written and oral English communication skills.

Leadership required in alignment with Company Leadership Imperatives:

• Connect - Develop collaborative relationships with key internal and external stakeholders.

• Shape - Actively participate in departmental process improvement activities.

• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
  
  Location & Travel Requirements

• Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.

• Ability to travel approximately 20% depending on the phase of the program.