Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
Clinical Research Specialist
The 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.
Scope of work:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:
• 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;
• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
• May perform other duties assigned as needed;
• Is 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;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• 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.
Who are you?
- Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
• 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 & 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.
Strong leadership required in alignment with intenal 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.
LOCATION & TRAVEL REQUIREMENTS
• Primary location for this position is Diegem. At management discretion, the position may be performed remotely.
• Ability to travel approximately 20% depending on the phase of the program.
• 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 clinical trial.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.