Clinical Research Associate - Oncology

The Clinical Research Associate (CRA)will be the primary liaison between the Investigator sites and LumaBridge, responsible for overall site conduct and establishing important relationships with key site personnel. The CRA will perform key job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, LumaBridge SOPs and work practices while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients. CRAs are expected to work in a hands-on, highly visible and autonomous role. CRAs must have the ability to be flexible and represent LumaBridge in a positive and professional manner while collaborating across all levels with the clinical teams and Sponsors/vendors.

Reports To: Associate Director or Director, Clinical Operations or designee

Titles: Clinical Research Associate

Sr. Clinical Research Associate

Principal Clinical Research Associate

Location: This is a remote-based position. Occasional Site travel (<50% and subject to business needs). LumaBridge cannot guarantee the location of sites and CRAs should expect travel anywhere in the continental United States.

Responsibilities:

• Perform site selection, initiation, monitoring, and close-out visits of investigational sites for the LumaBridge portfolio of clinical trials.
• Manage the progress of assigned sites by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, data collection, and data query generation and resolution.
• Conduct monitoring activities, including, but not limited to the following:
• Ensuring PI oversight of all trial activities
• Source data review and verification with EDC fields
• Essential documentation review and reconciliation
• Investigational Product (IP) management and accountability
• Lab/kit supply management
• Develop collaborative relationships with investigative sites and personnel.
• Maintain communication with sites through frequent contact to ensure site compliance, adequate enrollment, and understanding of study requirements.

· Write and submit complete and accurate visit letters and reports of investigational site findings and update applicable CTMS.

· Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.

• Participate in audit preparations and follow-up, as needed.
• Review and address protocol deviations, data quality issues, and identify process improvements for assigned sites.
• Be a collaborative member of the study team: provide insight, updates, and strategies to improve processes.
• Ability to think critically while prioritizing tasks in an efficient manner to meet study deliverables.
• Contribute to CRF development and perform User Access Testing, as requested.
• Assist with other duties as assigned.

CRA

• Mentor junior or entry-level CRAs.
• Assist in the development and/or review of study plans, forms and tools, and site training materials.
• Expert in development of letters and reports or documents with limited revision/oversight required.

Principal CRA

· Conduct monitoring visit report review as needed.

· Expert in development of letters and reports / documents with limited to no revision/oversight required.

· SME (Individual contributor).

· Stay abreast of industry monitoring standards and implement across LumaBridge.

Qualifications:

• Bachelor’s degree in life science/biomedical/medical science with a proficient knowledge of the clinical/scientific terminology and methods common to the oncology therapeutic setting.
• 2+ years clinical research experience is required.
• 2+ years experience at a CRO or Sponsor required.
• Independent field monitoring experience of oncology clinical trials is required.
• Early phase oncology experience is preferred.
• Established track record of building key productive relationships with study investigators, site staff and internal study team personnel.
• Proficient knowledge and practical utilization of ICH- GCP and applicable regulatory requirements.
• Strong communication (written and verbal) and interpersonal skills.
• Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.
• Ability to independently prioritize tasks with excellent time management skills.
• Highly proficient in computer applications including Microsoft suite of applications, EDC and CTMS applications.
• Fluent in English (written and verbal)
• Ability and willingness to travel as required (<50%), to include possession of the appropriate qualifications per independent sites regulations (to include but not limited to vaccinations).

Sr. CRA:

5+ years monitoring experience; 1+ year CRA experience with LumaBridge preferred.

Principal CRA:

8+ years monitoring experience; 2+ years Sr CRA experience with LumaBridge preferred.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.