Clinical Research Associate - Bucharest

Clinical Research Associate
Bucureşti
Bucharest, Bucharest, Romania

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside
- achieving teams. Take your career farther than you thought possible.

Position summary

The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.

Key Responsibilities

Conduct site qualification, initiation, routine monitoring and
- out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP

Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites

Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.

Cultivate and sustain effective relationships with internal
- functional teams and external partners, including vendors, clinical sites, and key stakeholders.

Serve as the organization’s representative for clinical trials at the site level.

Motivate and influence sites to meet study objectives, including enrollment and retention goals.

Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method

Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner

Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.

Demonstrate understanding and proficiency working with targeted, centralized, remote and
- based monitoring approaches

Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators

Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance

Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor

Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.

Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.

In specific instances, may support
- up and submission related activities, including ICF reviews and collection of documents to/from site.

Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.

Support coordination of site activities related to database locks to ensure timelines are met as required locally.

Perform timely site closure activities when all required protocol visits and
- up are completed.

Qualifications & Experience

Degree/Certification/Licensure:

Bachelor’s degree required, preferably within life sciences or equivalent

Valid driver’s license (as locally required)

Experience:

Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role

Extensive experience and demonstrated strong performance in all aspects of the role.

Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred

Experience in the drug discovery/development process.

Competencies

Knowledge and understanding of clinical research processes, regulations and methodology

Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management

Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities.

Analytical thinking/critical thinking skills.

Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions (Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment

Organization and time management skills

Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders

Good verbal and written communication skills (both in English and local language)

Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc. )

Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning

Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory

Proficient in navigating and utilizing multiple clinical systems (e. g. , CTMS, e
TMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity

Software that must be used independently and without assistance (e. g. , Microsoft Suite)

Microsoft Suite

Clinical Trial Management Systems (CTMS)

Electronic Data Capture Systems (e
DC)

Electronic Trial Master File (e
TMF)

RBM tools and platforms (e. g. , Veeva, Medidata, Clue
Points).

Informații detaliate despre oferta de muncă

Firma:	Bristol Myers Squibb
Localiția:	Bucureşti Bucharest, Bucharest, Romania
Adăugat:	10. 10. 2025 Postul de muncă activ

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Clinical Research Associate Bucharest

Clinical Research Associate
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Bucharest, Bucharest, Romania

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