We are looking for a Senior CRA with a strong knowledge of prostate cancer and running medical device studies. You will need a passion for oncology to work with our client on UK based studies. Sites are in the UK and Dublin but we are open to UK and Ireland wide candidates with good medical device and oncology backgrounds. 

We can also consider contract or permanent for this role. 

Job Summary: We are seeking a Clinical Research Associate with expertise in conducting early Medical Device clinical trials in oncology and ideally prostate. The CRA will be responsible for managing and monitoring clinical studies in compliance with Uk and Ireland regulations, Medical Device Good Clinical Practice (GCP) guidelines, and study protocols. 

This role will involve ensuring developing the regulatory and ethics submissions specific to device studies, coordinating with local regulatory authorities and ethics committees, and providing guidance on local requirements for this. 

Responsibilities:

Manage and oversee the conduct of device clinical trials in the UK with centres in the UK and Ireland, ensuring compliance with local regulations, GCP, Device and study protocols

Ensure timely submission of trial-related documents specific to the trials to the appropriate regulatory authorities and ethics committees, following the requirements outlined in the legislation.

Coordinate with local regulatory authorities, for obtaining necessary approvals, authorizations, and amendments related to the studies.

Liaise with local ethics committees to obtain ethical approvals for the initiation and continuation of the studies.

Provide guidance and expertise on specific requirements for  trial conduct, including informed consent processes, data protection regulations, and reporting obligations specific to these studies.

Conduct site selection visits and assess potential investigational sites for participation in the studies, considering local feasibility and regulatory requirements.

Initiate, monitor, and close out early phase oncology studies clinical trial activities at investigative sites in compliance with study protocols, device, and local regulations.

Train site staff on regulatory requirements specific to the studies, device guidelines, and study-specific procedures.

Ensure proper documentation and maintenance of trial-related files specific to device  oncology studies, including essential documents and trial master files, in accordance with local regulations regulations and company SOPs.

Perform routine monitoring visits to assess data integrity, protocol compliance, and patient safety, while also ensuring compliance with local regulations specific to device studies.

Collaborate with cross-functional teams, including data management, project management, and medical affairs, to ensure the successful execution of medical device studies

Keep up-to-date with changes in local regulations medical device regulations specific to  oncology studies and disseminate knowledge to study teams and relevant stakeholders.

Qualifications:

Bachelor's degree in a scientific or healthcare-related field (Master's degree preferred).

Strong experience as a Clinical Research Associate/ Senior CRA, with specific experience in conducting oncology device and clinical trials in UK

In-depth knowledge of local regulations clinical trials regulations

Strong understanding of medical device and GCP guidelines and their application in  oncology studies.

Experience in managing submissions to local regulations regulatory authorities and ethics committees for medical device studies.

Excellent knowledge of local regulations-specific requirements for informed consent, data protection, and adverse event reporting specific to oncology studies.

Familiarity with the local regulations healthcare system and regulatory landscape related to early phase oncology studies.

Excellent communication and interpersonal skills, with the ability to build and maintain relationships with investigators, site staff, and cross-functional teams.

Detail-oriented with strong organizational and time management skills.

Proficiency in using electronic data capture (EDC) systems and other clinical trial management

Please contact Gail Kniveton for more information 

02089850565

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