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Senior Clinical Research Specialist

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Johnson & Johnson

2mo ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Galway

AI generated summary

  • You need a relevant degree, 2-4 years of clinical research experience, industry certifications, strong communication skills, and medical device experience preferred.
  • You will manage clinical trial execution, ensure compliance, oversee site interactions, develop trial documents, support data review, and mentor team members while adhering to regulations.

Requirements

  • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
  • BS with at least 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 is a plus.
  • Medical device experience is highly preferred.
  • 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 English communication skills.
  • Ability to lead small study teams to deliver critical milestones, as may be assigned.
  • 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.

Responsibilities

  • 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);
  • 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;
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
  • May act as Clinical Safety Coordinator for safety-related activities in clinical trials;
  • Performs other duties assigned as needed;

FAQs

What is the location requirement for the Senior Clinical Research Specialist position?

The candidate is required to live within a commutable distance of either Galway (IE), Diegem (BE), or Zuchwil (CH), but remote candidates may be considered in some cases.

What qualifications are needed for this role?

A minimum of a Bachelor’s Degree, preferably in Life Science, Physical Science, Nursing, or Biological Science is required. Advanced degrees and industry certifications are preferred.

How many years of experience are required for this position?

A Bachelor’s degree with at least 4 years, a Master’s degree with at least 3 years, or a PhD with at least 2 years of relevant experience is preferred.

What types of experience are deemed relevant for this role?

Previous experience in clinical research or a related field is required, with medical device experience highly preferred.

What are the main responsibilities of the Senior Clinical Research Specialist?

Key responsibilities include supporting the execution of clinical trials, managing site interactions, overseeing clinical trial documents and data, and mentoring team members.

Are there any specific skills required for this position?

Required skills include a good understanding of clinical research processes, strong communication and technical writing skills, and the ability to lead small study teams.

What does the company value in its workforce?

The company is committed to diversity, equity, and inclusion, fostering an inclusive environment where diverse backgrounds and perspectives are valued.

Are there opportunities for mentorship in this role?

Yes, the role involves mentoring team members as part of its responsibilities.

Is there a need for travel in this position?

Travel may be required depending on the specific needs of the clinical trials and site management activities.

What is the approach to health, safety, and environmental practices at J&J?

The company emphasizes compliance with health, safety, and environmental practices, following all applicable regulations and procedures.

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Johnson & Johnson

Hospitals and Health Care

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.