Regulatory Project Manager, Hematology / Oncology (Fully Remote)

Description

We are seeking an experienced Regulatory Project

Manager who will be responsible for regulatory coordination of complex clinical

research studies within assigned units, departments or divisions. In this role,

you will perform detailed reviews of clinical research protocols and utilize

that information to prepare, manage and submit all required study / regulatory

documents and all required applications and forms related to internal UCLA

requirements, FDA requirements, sponsor requirements, etc. Additionally, you

will work with study monitors to process, review and collect the appropriate

regulatory documents in a timely manner and in compliance with federal, state,

and university mandated laws, regulations and policies.

The ideal candidate will have at a minimum, 1+ years of budget / negotiating experience.

Salary offers are determined based on various

factors including, but not limited to, qualifications, experience, and equity.

UCLA Health annual salary range for this position is $78,500.00 - $163,600.00.

Qualifications

Required :

Minimum of 3+ years of experience of clinical research

coordination.

Interpersonal skills to effectively communicate information in a

timely, professional manner and establish and maintain cooperative and

effective working relationships with students, staff, faculty, external

collaborators and administration and to work as a member of a team.

Ability to set priorities and complete ongoing tasks with

competing deadlines, with frequent interruptions, to meet the programmatic and

department needs, while complying with applicable University policies and

federal and state regulations.

Analytical skills to assess clinical research protocols and

regulatory requirements, define problems, formulate logical solutions, develop

alternative solutions, make recommendations, and initiate corrective actions.

Close attention to detail to ensure accuracy in a fast-paced,

fluctuating workload environment.

Organization skills to create and maintain administrative and

regulatory files effectively as well as independently balance the various tasks

to ensure deadlines are met.

Demonstrated proficiency with Adobe and Microsoft suite software,

especially Excel, to perform daily tasks efficiently and accurately.

A learning and professional growth mentality so that new software

tools, systems, and processes can be adopted quickly and efficiently.

Demonstrated knowledge of clinical research concepts, policies and

procedures, and human safety protection regulations and laws.

Knowledge of and experience

working with a variety of local and external IRBs, scientific review and other

research committees, national cooperative group sponsors, industry sponsors,

federal and foundation funding organizations, etc.