Regulatory Analyst

Job description

Job location: Miami, FL


Employment Type: Full-time
Posted data: 2020-11-17
Req: R100043030
Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

Transforming Lives

The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.

With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.

The Clinical Research Services (CRS) division of the Sylvester Comprehensive Cancer Center is a centralized resource that enables cancer center clinical investigators easy access to support services to facilitate clinical trial management. These centralized services include assistance with protocol development, regulatory affairs expertise, IND submission, study budgeting, contract negotiation, coordination of research nursing, data management, and safety reporting for all types of studies, including therapeutic, non-therapeutic, prevention and screening trials. The CRS Office is responsible for providing multiple levels of support for clinical research activities throughout the Cancer Center.

This individual will be responsible for assisting the senior leaders of the Regulatory Department of the Cancer Center Division of Clinical Research Services (CRS) with the day to day operations of the office. This position requires knowledge of IRB policies and procedures, and Federal Regulations for clinical trials. The Regulatory Analyst must be able to assist on the following studies:

  • Investigator Initiated Trials (IITs)

  • Industry Sponsored Trials

  • Cooperative Group Sponsored Trials

  • Compassionate (emergency/single patient) Trials.

JOB FUNCTIONS:

  • Prepare and Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.

  • Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required.

  • Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations. This process will take place from study activation throughout the completion of the study.

  • Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.

  • Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.

  • Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.

  • Communicate with Clinical Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit.

  • Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.

  • Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request. This responsibility is sponsor dependent.

  • Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.

Education:

Bachelor’s Degree in relevant field

Certification and Licensing:

Not Applicable

Experience:

Minimum 1 year of relevant experience

Knowledge, Skills and Attitudes:

  • Knowledge of relevant federal, state, and local regulations

  • Knowledge of procedures associated with clinical trials

  • Ability to maintain effective interpersonal relationships

  • Ability to communicate effectively in both oral and written form

  • Skill in collecting, organizing and analyzing data

  • ficiency in computer software (i.e. Microsoft Office

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

c104

 

 

 

Diversity Profile: University

 

AAUP COMPENSATION SURVEY DATA

View more

Learn more on Inside Higher Ed's College Page for University

Arrow pointing right
Job No:
Posted: 11/18/2020
Application Due: 2/16/2021
Work Type:
Salary: