We are looking for a great Senior Clinical Research Associate or CRA with expertise in conducting early Phase Oncology clinical trials in Sweden for a UK Biotech. For Sweden this is one site so we are expecting 0.2 FTE roughly 1 day/ week but this could increase. Perfect for freelancers.

The CRA will be responsible for managing and monitoring clinical studies in compliance with local regulations, Good Clinical Practice (GCP) guidelines, and study protocols. 

This role will involve ensuring adherence to local clinical trials regulations specific to early Phase I studies, coordinating with local regulatory authorities and ethics committees, and providing guidance on local regulations and specific  requirements for early Phase oncology trials.

Responsibilities:

• Manage and oversee the conduct of early Phase clinical trials in Sweden, ensuring compliance with local regulations, GCP, and study protocols.

• Ensure timely submission of trial-related documents specific to early Phase I 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, GCP, and local regulations.

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

• Ensure proper documentation and maintenance of trial-related files specific to early phase 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 early phase oncology studies.

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

• Keep up-to-date with changes in local regulations clinical trials regulations specific to early phase 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 early Phase I clinical trials in Sweden.

• In-depth knowledge of local regulations clinical trials regulations

• Strong understanding of GCP guidelines and their application in early phase oncology studies.

• Experience in managing submissions to local regulations regulatory authorities and ethics committees for early phase oncology studies.

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