Senior Clinical Research Specialist

Job not on LinkedIn

November 25

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

OneTrust

WebsiteLinkedInAll Job Openings

Compliance • Cybersecurity • Data & AI Governance

OneTrust is a comprehensive platform that empowers organizations to responsibly collect, govern, and utilize data with complete visibility and control. It provides solutions for consent and preference management, third-party risk management, privacy automation, and tech risk compliance, ensuring adherence to regulatory standards while fostering innovation. By helping businesses manage their data lifecycle effectively, OneTrust helps safeguard data from various risks including privacy concerns and IT vulnerabilities, thus maximizing the value of data and AI in line with organizational policies.

1001 - 5000 employees

📋 Compliance

🔒 Cybersecurity

💰 $6.4M Venture Round on 2022-07

📋 Description

• Serves 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, for operating company. • Oversees/executes 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). • Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,etc.). • Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed. • Manages and oversees ordering, tracking, and accountability of investigational devices and trial materials. • Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel. • Interfaces, collaborates, and oversees Clinical Research Associates (CRAs). • Oversees and supports the development and execution of Investigator agreements and trial payments. • Is responsible for 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 contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects. • May provide on-site procedural protocol compliance and data collection support to the clinical trial sites. • Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated. • Contributes 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). • May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals. • May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant. • Supports project/study budget activities. • May act as Clinical Safety Coordinator. • Mentors team members. • Responsible for communicating business related issues or opportunities to next management level. • Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders. • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures. • Develops a strong understanding of the pipeline, product portfolio and business needs. • Generally manages work with supervision, dependent on project complexity. • Utilizes independent decision-making for simple to advanced situations but requests guidance for complex situations. • Responsible for communicating business related issues or opportunities to next management level.

🎯 Requirements

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required ; Advanced Degree strongly preferred • At least 4+ years (2+ with Advanced Degree) of relevant field-based Clinical Research experience beyond monitoring and/or lab work required • Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations required • Combination of CRO & In-House experience highly desired • Medical device experience highly desired • Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.) • 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. • Ability to travel approximately 20-25% depending on the phase of the program.

🏖️ Benefits

• medical • dental • vision • life insurance • short- and long-term disability insurance • business accident insurance • group legal insurance • retirement plan (pension) • savings plan (401(k)) • vacation –120 hours per calendar year • sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year • holiday pay, including Floating Holidays –13 days per calendar year • work, Personal and Family Time - up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member • Caregiver Leave – 10 days • Volunteer Leave – 4 days • Military Spouse Time-Off – 80 hours