Clinical Research Associate

Summary

The Clinical Research Associate (CRA) is responsible for monitoring clinical study sites during study start-up, study recruitment, and follow-up and close out study phases. In addition, the CRA will support site initiation visits, platform/process training, clinical education, sample collection oversight, implementation of subject recruitment strategies, and communicating with appropriate site staff and investigators for the successful completion of studies. This role will be responsible for site-related KPIs for data entry, including data completion, query resolution and data validity. The candidate will be a dynamic thinker with an intellectual curiosity and an ability to optimize clinical site engagement and effectiveness. Travel is expected to be up to 50% for this position.

Job Duties/Essential Functions

• Perform remote and/or in-person site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with protocol(s) and Good Clinical Practice.
• Administer protocol and study related training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Support regulatory document collection, tracking and maintenance.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Assist Clinical Team with filing documents in the TMF.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• May be accountable for supporting development of project subject recruitment plan on a per site basis, if applicable
• Be part of the Elephas clinical team, interacting with consultants, Contract Research Organizations, and other vendors, if applicable

Competencies

• Demonstrates excellent knowledge of ICH/GCP
• Displays ability to manage investigative sites to facilitate trial deliverables
• Demonstrates ability to escalate issues appropriately
• Demonstrated expertise in discussing and explaining scientific content
• Demonstrates strong ability to engage and galvanize sites to complete study tasks, such as data entry, query resolution and patient recruitment
• Demonstrates excellent written and oral communication
• Strong attention to detail
• Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, and Electronic Data Capture platforms

Required Education and Experience

• Bachelor’s Degree required. Bachelor’s Degree in a scientific or healthcare-related field highly preferred
• Minimum of 2 years of experience as a Clinical Research Associate
• Previous on-site monitoring experience required
• Minimum of 5 years in the clinical research industry at the site, sponsor or CRO level
• In-depth knowledge of oncology clinical trials, specifically solid tumors

Travel

Travel is expected to be up to 50% for this position

We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.