Clinical Research Associate/Site Monitor

1+ years

Not Disclosed

Remote, USA

10 Aug. 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Sponsor-Dedicated Site Monitor - Belgium

About Parexel:

Parexel is a global leader in clinical research, supporting studies across a diverse range of therapeutic areas. We have a rich history of partnering with major pharmaceutical companies and have played a key role in the development of many of today’s top-selling drugs. We are committed to enhancing patient well-being and offer a collaborative environment where you can make a significant impact.

Role Overview:

We are seeking a Site Monitor with oncology trial experience to join our team in Belgium. This role focuses on ensuring data integrity, quality, and compliance with ICH-GCP and local regulations at the site level. Monitoring will primarily be virtual, with occasional on-site visits as required. The Site Monitor will work closely with the Site Manager to ensure compliance with study protocols and maintain site inspection readiness.

Key Responsibilities:

Monitoring and Compliance:
- Ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols. Use judgment and experience to assess site performance and recommend site-specific actions.
- Verify that informed consent processes are performed and documented correctly.
- Protect subject confidentiality and assess factors affecting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
- Conduct monitoring activities both on-site and remotely according to the Clinical Monitoring Plan (CMP) or Study Monitoring Plan (SMP).
Data and Documentation:
- Perform source document reviews and verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs).
- Manage protocol deviations, apply query resolution techniques, and provide guidance to site staff.
- Conduct Investigational Product (IP) inventory, reconciliation, and verify IP dispensation and administration.
- Document activities via monitoring reports, follow-up letters, and other required project documents.
- Ensure all site personnel are properly delegated and trained, and review data entry, training compliance, and site-specific logs.
Collaboration and Communication:
- Collaborate with the Site Manager and act as a liaison with site personnel.
- Prepare for and attend Investigator Meetings and sponsor meetings.
- Participate in global clinical monitoring and project staff meetings.

Who We Are Looking For:

Skills:

Excellent networking and relationship-building skills.
Strong communication skills, both verbal and written, with the ability to interact effectively with internal and external stakeholders.
Ability to adapt to evolving technologies and processes.
Proficiency in local language and advanced fluency in English.

Education and Experience:

Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training, and experience.
Proven experience with oncology trials is essential.
Demonstrated ability to manage complex protocols and adapt to changing priorities.

Not Quite the Right Fit?

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Clinical Research Associate/Site Monitor

Job Description

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