| Regulatory Manager-Cancer Research Office -- Worcester, MA |
Author: Meredith Hanrahan-Boshes
Date: 07-12-11 19:50
To apply: Visit our website at www.umassmed.edu, click on Human Resources, Job Opportunities, Search for Req # 20561.
GENERAL SUMMARY OF POSITION:
Under the direction of the Director or designee the Regulatory Supervisor supervises the regulatory group in the coordination and preparation of document packages for submissions to the FDA pharmaceutical and biologics manufacturing organizations the National Cancer Institute the local IRB and other agencies. The Regulatory Supervisor is responsible to develop direct and implement compliance program components as required by FDA guidance regulatory procedures and changes pertaining to complex treatment ancillary and prevention protocols regulated by the FDA or DHHS and sponsored by federal agencies foundations industrial sponsors or the University of Massachusetts Medical School.
Description: MAJOR RESPONSIBILITIES:
* Responsible for ensuring compliance with policies regarding the use of human subjects in research
* Develop direct and implement compliance program components; including protocol and consent form review record keeping monthly and annual reporting program evaluation and other compliance issues that meet the applicable government and local regulations and the institution's policies and practices
* Pro-actively identify protocols that need special review or procedures
* Assist investigators and study teams in preparing and submitting FDA IND applications. Interact with FDA on matters of inquiry and compliance resolution of IND issues
* Prepare ongoing summary reports of various data sources and collaborates with investigators on data presentation interpretation and the writing of manuscripts for publication and grant proposals
* Prepare submissions of regulatory documents for research regulatory and local bio-safety committees
* Direct regulatory compliance operations initiate modification of existing policy and develop new SOPs and training materials
* Oversee paper and electronic submissions to local IRB and other reporting entities as appropriate (federal industry) of protocol protocol amendments IND safety reports ADEERS consent form changes continuing reviews violations and deviations to study protocols
* Responsible for maintaining updating and auditing the regulatory tracking/control systems to insure compliance with regulatory timelines license renewal and annual registrations
* Manage the recruitment and hiring of regulatory staff. Responsible for orientation work assignment supervision training and performance evaluation of Regulatory Specialists Assistants and other personnel as assigned
* Coordinate relationships with affiliated research sites to insure regulatory compliance oversight and reporting
* Coordinate and lead site external affiliate audits. Includes preparation execution recommendations and final reporting
* Maintain confidentiality regarding subjects records and review of issues
* Serve on departmental committees (e.g. Data Safety Monitoring Committee Audit Committee) as required to provide regulatory insight and guidance. Represents the department regarding regulatory issues at institutional meetings and public venues
* Perform other duties as required.
MINIMUM QUALIFICATIONS:
* Bachelor's degree in a scientific or health care field or equivalent experience
* 3-5 years of clinical trial regulatory experience required experience in oncology clinical trials preferred
* 1 year of experience in training and supervision of staff in a regulatory compliance performance
* Strong knowledge of medical terminology and ability to interpret complex clinical protocols for regulatory management purposes
* Must demonstrate good understanding of the Federal Code of Regulations TITLE 21 FDA GCP ICH NCI Cooperative Group and OHRP regulatory guidelines
* Demonstrated knowledge with electronic regulatory management platforms Microsoft Office Suite and industry related software
* Strong critical thinking skills proofreading skills and attention to detail
* Superior organizational skills with demonstrated ability to juggle and prioritize multiple tasks in a fast-paced environment and consistently meet deadlines
* Excellent interpersonal skills and ability to work collaboratively with other research academic and clinical personnel at the local and national level
* Excellent written and oral communication skills
* Ability to travel to off-site locations.
Starting Salary: based on relevant experience
|
|
| Topics |
Author |
Date |
  |
Regulatory Manager-Cancer Research Office -- Worcester, MA |
|
Meredith Hanrahan-Boshes |
07-12-11 19:50 |
|
