Hybrid: On site Monday, Wednesday and every other Friday.

Job Description

This Senior 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.

DUTIES & RESPONSIBILITIES*

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

Serve as a Senior 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;

Perform other duties assigned as needed;

Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.

Education

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

Experience

BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.

Previous experience in clinical research or equivalent is required.

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

Clinical/medical background a plus.

Medical device experience highly preferred.

Functional and Technical Competencies:

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

2. Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
   

3. Good presentation and technical writing skills;
   

4. Good written and oral communication skills;

Leadership Competencies:

Ability to lead small study teams to deliver critical milestones, as may be assigned.

Leadership required in alignment with Leadership Imperatives:

Connect – Develop collaborative relationships with key internal and external stakeholders. Shape - Make recommendations for and 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. At management discretion, the position may be performed remotely.

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

EXTERNAL INTERACTIONS

Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.

May have regular interaction with third party vendors supporting clinical studies as applicable per program.

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