IIR Grant Associate

Apply by eMail:15323979.185@jobfrenzy1.com

Description:
The Contract IIR Grant Associate provides primary support to Global IIR Managers with necessary internal and external communication and coordination to ensure efficient processing of Investigator Initiated Research (IIR) requests. The IIR Grant Associate is responsible for. The IIR Associate works in Tandem with the IIR Manager in: ensuring accuracy of IIR proposals into the system, monitoring proposal status and securing study closure documentation coordinating externally with: Principal Investigators, research sites, co-op groups, relevant government agencies (eg, NIH, NCI), alliance partners, vendors, coordinating internally with Pharmaceutical colleagues, including TA Medical Teams, RMRSs, PCOs, EBTs, and Regions, PGRD, Worldwide PharmSci, Contracts and Outsourcing, Safety and Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance. Organizational Relationships: TA Medical Teams, Finance, Contracts and Outsourcing, Legal, Regulatory, RMRS, PCOs, Clinical Supply Resources Managed (budget and FTEs): No direct reports. Informal sharing and coaching of MCEG colleagues on best practices. Primary Duties: Reviews incoming IIR requests and documents for accuracy and completeness in the IIR database Contacts requestors for missing or requested documentation as appropriate. Issues correspondence to IIR requestors and colleagues, including acknowledgement letters to requestors and communications to Review Committee members, RMRS, Regional, or PCO colleagues. Manages distribution of documentation, preparation of agendas, and required scheduling coordination necessary for Review Committee meetings, as directed by IIR Managers. Forwards IIR request data to Contracts and Outsourcing and reviews initial contracts created for correspondence with initial request, as directed by IIR Managers. Generates Clinical Supply Requests and coordinates with Clinical Supply to ensure clinical supplies are available as required for IIR studies. Manages the transactional details of payment requests and documentation with Finance, NASS or other appropriate Pharmaceutical colleagues, as directed by IIR Managers and works with them to resolve payment processing issues. Inputs IIR study milestones into the IIR system. Generates of requests to investigators for enrollment sweeps and study progress updates, and forwards documents received to IIR Managers. Assists IIR Managers with status report queries, as required. Contributes to process and technology improvement projects within areas of responsibility, as requested. Training and Education Preferred: Bachelors Degree Other Qualifications: Knowledge of FDA Guidances Knowledge of Windows NT/2000/XP, publishing and scanning software Excellent oral and written skills Proven track record of organizational, interpersonal, and multi-tasking skills Prior Experience Preferred Prior pharmaceutical experience preferred. Familiarity with products and medical research terminology Strong understanding of Investigator business processes In-depth knowledge of IG/INSPIIRE, Clinicopia, GDMS, Pegasus, CSDS databases Demonstrated proficiency with computers, the Microsoft family of software, databases, including logical data structures and reporting, as well as Website development and maintenance Working across Matrix teams Practical experience with electronic document management and publishing technologies, drug development methodology and regulatory guidelines. Technical Competencies: Competency Detail/Comments (specific skills, etc.) Technical Knowledge Strong knowledge of the principles and concepts of Investigator Initiated Research based on experience in Clinical Study or IIR study management, or a related discipline. Understanding of drug product(s), disease characteristics, and research or study design. Proficient with computer based tools and systems (eg, tracking, financial, clinical supply, investigator credentialing, document management, etc.) used to support IIR study management. Assumes responsibility, with supervision, for selected parts of study(ies) (eg, drug supply forecasting and ordering, patient enrollment, tracking). Completes study-specific tasks and contributes to the delivery of milestones. Identifies when issues are beyond own expertise and seeks input from appropriate team members (eg, more senior colleagues). Performs assignments using established procedures and general instruction on the process and desired outcome. Decision Making Makes decisions to resolve moderately complex problems. Responds appropriately to routine questions raised by RMRSs, PCOs, and other internal stakeholders. Interacts with external investigators and HCPs regarding the status and operational issues with IIRs Correctly interprets and executes routine application of SOPs and processes. Makes appropriate decisions related to maintaining a high level of data integrity and process compliance.

Requirements:
See Above

Education: Not Specified

Experience: Not Specified

Travel: Not Specified

Apply by eMail:15323979.185@jobfrenzy1.com

Job Created: Sat Oct 10 2009 04:29:22 AM
Last Modified: Sat Oct 10 2009 04:29:22 AM