Clinical Research Specialist

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Clinical Research Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines where you will in a hybrid model in Diegem, 1.0 FTE. In this you 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.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. 

Main Job Tasks And Responsibilities:

• 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, for Company Electrophysiology 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.

Education And Experience:

• 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.
• Leadership required in alignment with Company Leadership Imperatives:
• 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.
• 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.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About Clinchoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Freelance Clinical Research Specialist, Clinical Trial, ICH-GCP, Regulatory, Medical Devices, Contract Research Organisation, CRO.

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