Clinical Research Coordinator

Clinical Research Coordinator

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Job Description

The Clinical and Research Collaboration (CRC) Liaison has primary responsibility for the oversight and management of clinical and research collaborations within assigned Therapeutic Area(s).

Clinical and research collaborations are research studies/programs and partners with an external collaborator(s) to develop, conduct and execute research that would be used to support the business or regulatory goals.

The CRC Liaison will be in support of at least two or more Business Units and/or Research Units that engage with external (third party) collaborators that include but are not limited to principal investigators, research organizations, co-op groups, relevant government agencies (e.g., NIH, NCI), other pharmaceutical companies, drug safety monitoring boards, alliance partners, and any vendors that support CRC activities.

The CRC Liaison ensures the timely due diligence review of CRC proposals, contract generation and execution, and forecasts and coordinates drug shipments across the program globally.

This due diligence ensures that proper oversight, risk identification and mitigation are addressed before and during these collaborations with third parties. The CRC Liaison also oversees study progress and collaborates with colleagues to ultimately ensure compliance with CRC processes, systems and regulations.

Internally, the CRC Liaison is the primary Point of Contact for colleagues, including TA Medical Teams (within the Business Units and Research Units), RMRSs, PCOs, and Regions, PGRD, Worldwide PharmSci, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance.

The CRC Liaison also monitors the CRC-related systems and educational needs of internal and external stakeholders to maintain compliance with CRC policies and guidelines as well as external healthcare law throughout the process.

The CRC Liaison will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve CRC functions globally across an asset program.

Manages CRC requests from development to close.

Partners with the Project Lead and Legal to work with external collaborator(s) to develop research collaboration proposals.

Supervises initial review for completeness and classification of CRC proposals, entry of information into the CRC system, and requests for additional information or documentation through the entire lifecycle of assigned CRC studies.

Liaises with the Project Lead and Legal and external collaborator(s) of CRC proposals, especially those that will require or more sophisticated handling for review and decision. (e.g., proposals from co-operative groups or partnerships) Leads CRC Due Diligence Internally.

Informs CRC Functional Line Subject Matter Experts about the proposal and manages their due diligence activities on the CRC proposal.

Manages and facilitates Kick-Off and review meetings of Functional Line SMEs, Project Lead and Legal that review and make decisions about CRC proposals.

Ensures appropriate and efficient follow-up of Due Diligence including action items and decisions, developing Task Ownership Matrices and Oversight Plans between external collaborator(s).

Collaborates with internal and external partners and stakeholders.

Responds to queries from RU/BU ELTs about the status of assigned CRC proposals, studies, and CRC policies and procedures and other internal and external stakeholders, as required.

Interacts directly with Collaborator(s), research sites, co-operative groups and public or private sector intergroup and networks globally to facilitate process and execution of CRC studies within assigned TA and to ensure compliance with CRC policy, global and local healthcare laws.

Partners with the Project Leads to manage relationships with PCO and Regional colleagues as required for management of CRC proposals globally as needed.

Works with Reporting and Analytics Lead to provide detailed summaries and reports for asset or TA leadership and informs decisions on the management of CRC programs Mediates in the generation of CRC contracts.

Facilitates and monitors the efficient and accurate creation of contracts and amendments for CRC studies new or ongoing with Legal.

Liaises with the Project Lead and Legal and external collaborator(s) of CRC proposals, especially those that will require or more sophisticated handling for review and decision and due diligence activities for amendments (e.g., proposals from co-operative groups or partnerships) Secures and manages clinical supplies and vendors.

Forecasts study drug supply requirements, and initiates requests for clinical supply.

Works with PharmSci colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.

Manages study drug supply inventories, and ensures timely deliveries to sites.

Monitors study milestones and requests for additional supply and funding.

Qualifications

Experience in infectious diseases or vaccines Clinical study experience

No Overtime/Some travel (4-5 times per year)

Minimum of a BS/BA is required with preference for a focus in science or biomedical discipline. (Candidates with equivalent experience as defined below may be considered)

Master's degree, Advanced education and/or training/experience preferred.

Prior Experience in clinical study management or research collaborations is required

Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change.

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable.

Additional Information

Technical Knowledge-

Strong working knowledge of the scientific and operational issues relevant CRC to study design, drug product(s), disease characteristics, and relevant scientific and operational aspects of drug development.

Solid understanding of GCP, HCL, Regulatory, Safety, and laws applicable to CRC studies

Comprehensive knowledge of appropriate SOPs, processes and systems

Good understanding of other functional areas (e.g., Clinical Supply, Finance, C&O) and organizations (e.g., RMRS and Regions including U.S.)

Experience with financial and CRC drug supply forecasting

Adept at the use of computer based tools and systems (e.g., tracking, financial, document management, etc.) used to support CRC study management (i.e. CRC system)

Excellent written and oral communication skills

Excellent project management skills; capable of managing two or more CRC asset programs at the same time

Provides end-to-end management of CRC processes for multiple asset programs from review to implementation and close.

Brings results to the appropriate attention of Medical to demonstrate ROI.

May serve as an SME for a specific activity related to continuous improvement (e.g., SOP or process).