Clinical Research Specialist

Clinical Research Specialist   

Location: Diegem - Belgium (hybrid working)

Travel: approx 25% local and EMEA (driving licence required)

Duration: 12 Months Contract

Hours: 40

The role

Under general direction, 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.

 Key Job Activities: 

• 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; 

• 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. Independent decision-making for simple 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. 

how to succeed

Education 

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

Experience 

• 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.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and  AFFILIATIONS

Functional and Technical Competencies: 

• 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 Competencies: 

Leadership required in alignment with J&J 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. 

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”