The In-House Clinical Research Associate is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.

The IHCRA is responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities are to be conducted in compliance with Company or Sponsor SOPs, regulatory standards and applicable guidelines.

Responsibilities include:

1) To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
2) To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.
3) To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL
4) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits)
5) To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.
6) To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by management
7) Might be requested to work in a client facing environment as assigned.
8) General On-Site Monitoring Responsibilities per the monitoring plan.

9) To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
10) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.

Requirements:

- University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology)

- OR 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries

- Basic understanding of ICH-GCP guidelines
- Basic understanding of the clinical trial process

- Fluent Dutch, French and English languages

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