• Address: New York, NY 10008 (map)
• Date Posted: 10/31/09
• Job Type: Full-time

Company Axelon Services Corp
Position Title IIR Grant Associate
Job Code 2862983
Job Location NYC, NY -
Description




IIR Grant Associate


Location: NYC

Duration: 1 year contract

Position Purpose


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 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 client colleagues, including TA Medical Teams, RMRSs, PCOs,

EBTs, and Regions, PGRD, Worldwide PharmSci, Contracts & Outsourcing, Safety & Risk

Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance.


Organizational Relationships:

TA Medical Teams, Finance, Contracts & 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 pharmaceutical client 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 & 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 client 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 & 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 pharmaceutical 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 & 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.

Behavioral Competencies:


Competency Detail/Comments (specific skills, etc.)

Autonomy Exercises judgment utilizing standard methods and techniques.

Assumes responsibility for, and organizes, a portion of or an entire studies milestones and deliverables.

Identifies when issues are beyond own expertise and seeks input from appropriate team members (eg, more senior colleagues).

Respectfully challenges decisions or ideas to uphold integrity and ethical standards.

With limited supervision, reliably completes defined study responsibilities (eg, enrollment tracking, drug re-supply).

Contributes to process and technology improvement projects within area of responsibility.

Teamwork/Collaboration Develops effective and productive partnerships within the individuals area of responsibility to aid in delivery of project goals.

Participates and contributes as an IIR study team member.

Shares best practices and strives for continuous improvement.

Takes responsibility for a portion or all of the IIR study teams milestones and deliverables (eg, conducting enrollment sweeps).

Proactively identifies complex problems on specific IIR study(ies) and helps determine solutions.

Desired Skills:


Non-Tech Skills:



Start Date: ASAP
Emp. Type: Contract-to-Hire
Duration: 1 year contract
# of Openings: 1
Location: NYC, NY -
Overtime Pay: None
Job Number: 35755783 : JS09-08193
Date Posted: 10/29/2009

Axelon Services Corp

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