Clinical Research Associate II

General Description:

The CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible for building and maintaining relationships with key site personnel and ensures an effective line of communication.

The CRA will also monitor data quality and patient safety through monitoring and site education.

CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.

Essential Functions of the Job:

• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices

• Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation

• Develop collaborative relationships with investigative sites, and study vendors

• Provide protocol and related study training to assigned clinical study sites

• Attend disease indication and/or project specific training, as required

• Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues

• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues

• Communicate site performance to the Clinical Study Team (CST)

• Perform study-specific training with project team

• Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies

• Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).

• Attend regional investigator meeting and site booster visits, as required

• Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed

• Assist with other assigned clinical responsibilities within scope of role, as required

Supervisory Responsibilities:

• Provides site level management for established protocols and portfolio under general supervision

• Provides mentoring/support to CRAs for CRA related topics

• Co-monitoring with CRAs and support site visits, as needed

Computer Skills:

• Efficient in Microsoft Word, Excel, PowerPoint and Outlook

• Familiar with industry CTMS and data management systems

• undefined

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• Excellent communication and interpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Fluent in English (writing and speaking)

Travel:

• Up to 70% travel

Education/ Education Required:

• BS/BA in a relevant scientific discipline and minimum of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring experience.

• Experience in global oncology trials preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.