Senior Clinical Research Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

Key Responsibilities:

Under general direction, 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.

In accordance with all applicable federal, state and local laws/regulations and Corporate JNJ MedTech, procedures and guidelines, this position:

• 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;
• 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,….);
• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
• Manages/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; 
• Mentors team members;
• Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Should develop a strong understanding of the pipeline, product portfolio and business needs;
• Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations.
• Responsible for communicating business related issues or opportunities to next management level;
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable;
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable;
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
• Performs other duties assigned as needed;
• May act as Clinical Safety Coordinator:
  • Coordination of all safety-related activities of clinical trials;
  • Strategic planning and coordination of all new safety initiatives;
  • Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research;
  • Cooperation with the necessary stakeholders (clinical study team, medical, clinical sites, regulatory, data management) on safety activities related to clinical studies and guarantee adherence to the SMP;
  • Works with data management to ensure timely database notifications to relevant parties;
  • Coordinates the collection of required information on safety events with the clinical study team;
  • Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study;
  • Coordinates review of clinical safety data with the clinical study team, Medical Affairs or Medical Safety team;
  • Ownership of the study safety inbox and coordination of timely reporting of study adverse events to competent authorities and ethics committees;
  • Create safety reports for reporting to internal stakeholders, investigators, ethics committees and authorities;
  • Assists in scheduling and coordination of safety adjudication process;
  • Coordinates safety board meetings and acts as point of contact for any questions;
  • Ensures all safety reports are directed to the appropriate staff.

Qualifications:

Education

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

Experience

• BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience required.
• Previous medical device Clinical Research experience in the area of interventional cardiology or electrophysiology is strongly preferred.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
• Clinical/medical background a plus.
• Up to 20% travel is required for this role.

Functional and Technical Proficiencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
• 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;
• Good presentation and technical writing skills;
• Good written and oral communication skills

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  ([email protected]) or contact AskGS to be directed to your accommodation resource.

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