Job Summary:

Primarily responsible for the day-to-day activities of managing, coordinating and executing the operational efforts for Clovis Investigator Initiated Trials (IITs), with specific emphasis on the startup and execution of biomarker and pharmacokinetic research details for each IIT.  Knowledge of the drug development process and documented experience working cross functionally across a Matrix Organization is critical.

This CRA2/Sr. CRA will coordinate primarily with colleagues in Global Medical Affairs, Project Management, Molecular Diagnostics and Translational Medicine, Translational Medicine Operations, and Clinical Operations, to ensure robust clinical sample management that complies with IIT protocols, timelines, and budgets. The Sr. CRA will be responsible and accountable for managing/overseeing the entire sample set up and management process for IITs through analysis and final disposition.

The successful candidate will employ their Clinical Operations and project management skill sets in support of Clovis IIT research efforts, and will work closely with colleagues to manage biomarker/PK research with high scientific integrity. Additional responsibility may be assumed for other aspects of the IIT program as they become available. 

As Clovis continues to grow, the CRA2/Sr. CRA will be a key contributor towards improving existing processes and establishing new ones, including but not limited to developing/writing work instructions and SOPs to ensure effective and efficient execution of IITs. 

Job Responsibilities

• Work closely with Global Medical Affairs and Translational Medicine to coordinate and manage the sample collection (tissue/blood) for on-going and planned IITs that have biomarker/PK objectives in their design.
• Manage kit preparation, sample collection procedures, shipping requirements, analytical data collection/reporting for IITs.
• Ensure robust chain-of-custody for IIT trial specimens, as needed.
• Manage contracts (material transfer agreements/clinical sample agreements) with academic institutions and/or commercial partners that provide biospecimens to Clovis as part of IIT collaborative or service provider agreements.
• Ensure/verify that collaborators (institutions, tissue banks) have appropriate documentation, process and procedures in place to ensure samples are collected according to ethical and legal standards (both prospective and retrospective sampling).
• Manage IIT vendor budget negotiations.
• Coordinate with GMA on IIT budget negotiations, as needed.
• Provide IIT vendor budget forecasts that relate to all aspects of sample management (acquisition, transport, storage, analysis).
• Track, process, pre-approved IIT vendor invoices.
• Develop knowledge/understanding of regional biospecimen/biobanking applicable regulations to help facilitate protocol approvals by global ethics committees.
• Coordinate with Clovis Diagnostic Development partners on IIT work.
• Work closely with Medical Science Liaisons to obtain IIT proposals, collect documents, and interface with investigators and relevant site staff.
• Assists in managing aspects of IIT Contracts, including management of milestones achieved and associated invoicing and payments.
• Interact with Investigators and their IIT teams regarding study logistics, progress, and issues.
• Provide management with updates/metrics on progress of IITs at routine intervals, by various tracking mechanisms.
• Collaborates effectively with cross-functional management teams and external partners.
• Proactively identify and remediate IIT issues related to samples.
• Effectively collaborates with Clinical Operations and other colleagues (e.g., Medical Affairs) for input and information exchange to ensure success of all studies/programs.
• Develop, review, update, and add SOPs as company/situations evolve when applicable.
• Develops effective working relationships with business partners to achieve business goals.

Qualifications

• Strong project management, organizational skills, ability to prioritize and handle competing priorities.
• Knowledge and experience with a wide variety of vendors providing services for clinical and translational research.
• Experience with contract and budget development/forecasting, negotiation, vendor management; sample management.
• Experience in working across operational, research, regulatory and legal functions
• Excellent team player.
• Excellent verbal and written communication skills with the ability to communicate effectively in the English language in person, by phone and in writing.
• Good judgment and strong problem solving skills.
• Builds successful collaborations with internal and external partners.
• Detail oriented and committed to providing quality deliverables.
• Positive, flexible, self-starter, able to multi-task, manage change, and thrives under pressure
•  Knowledge of GCPs for global compliance.
• Computer proficiency (MS Word, Excel, PowerPoint).

Education and Experience:

• BS or MS degree in biology or life sciences, with a strong background in health care, other scientifically related fields, or bio/pharma industry working on clinical development projects.
• 5 + years of experience in industry.
• Experience in US/Ex-US Investigator Initiated Trials desired.

This is an office based position with some travel, approximately 10% domestic and 5% international.