Aids Healthcare Foundation Work Values

Daily Duties at Aids Healthcare Foundation:

• Established and tracked clinical study milestones/timelines for the site(s); • Effectively communicated relevant project information to management and peers. • Spearheaded all regulatory activities for all study protocols; including responses to the IRB, sponsor, and monitor inquiries for up to 20 clinical trials; gained experience with IRB submissions to various IRBs. • Developed and negotiated study contracts and grants, including budgets, with sponsors and universities. • Reviewed study contracts/budgets and provided relevant budgetary limits to the appropriate departments; approved site invoices based per contract allowances. As needed, provided budget accrual projections. • Reconciled payments with study activities to ensure all payments had been received. • Collaborated with Billing and Accounts Payable to ensure sponsors are billed based upon completion of study initiatives. • Ensured timely reporting of serious adverse events; followed-up and resolved data clarification queries. • Maintained ISF; ensured all necessary documentation was in compliance with GCP, ICH and CFR guidelines; including communicating with various sponsors and CROs (GSK, Tibotec, Gilead, Vertex, PPD, Quintiles and Parexel) to update all documents in the Clinical Trial Master File. • Resolved and/or escalated issues in a timely fashion.

What they like about Aids Healthcare Foundation:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets

Skills

clinical research regulatory procedure, clinical project manager, supervisor multiple employees, Maintained Trial Master File as in-house CRA, Protocol Writing, Negotiate budgets and contracts for clinical trials

These are some of the questions we asked our climbers about their experiences with Aids Healthcare Foundation: