IRB Specialist II - UF Health Cancer Center
Apply now (https://secure.dc4.pageuppeople.com/apply/674/gateway/default.aspx?c=apply&lJobID=525548&lJobSourceTypeID=796&sLanguage=en-us) Job no: 525548
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Allied Health, Social/Behavioral Science, Grant or Research Administration
Department: 29300500 - MD-CANCER CTR CLINICAL TRIALS
Clinical Research Coord I
As part of our Regulatory Affairs team, you will be responsible for independently collaborating with investigators, physicians, nurses, and other key personnel to manage sponsor and regulatory compliance for an assigned portfolio of clinical trials.
In your new role you will be responsible for the following:
Managing a portfolio of clinical trials for which you will be responsible for the regulatory submission and compliance of these trials. You will be responsible for working with investigators and assigned study coordinators to promote patient safety and research integrity within your portfolio, including aiding in study audits, reviewing study documents, communicating industry changes, enforcing regulatory requirements, and participating as part of the study team in relevant meetings and events;
Coordinating and managing all new study submissions within the UFHCC; directing the submission process, lending expertise to sponsors, study teams, and investigators, as well as ensuring study documents and materials meet the standards necessary for activation. This will also include working closely with investigators to develop and draft research protocols and related documents for submission;
Continual study maintenance and upkeep, as needed per industry and regulatory changes. This will include ensuring correct documentation is retained, coordinating study revisions, and submitting any necessary reports. You will also be responsible for continuing review and coordinating the study close-out process for studies concluding their activities at the UF Health Cancer Center;
As an experienced IRB Specialist, you will also be responsible for assisting in the training and providing membership to Regulatory Affairs team members and/or clinical staff on regulatory compliance topics and best practices, as needed.
This is an early career position, ideal for candidates interested in further establishing a career supporting clinical research. In order to be successful, candidates should have direct experience working as a study coordinator or in regulatory support for clinical research.
This position reports to theRegulatory Affairs Manager (https://directory.ufhealth.org/toon-tonia) . A complete job description will be provided to candidates selected for interview.
$ 42,000 - $47,500 ; Commensurate with Education and Experience.
Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Bachelor’s Degree in Basic Sciences, Health Administration, Public Health, or similar.
Three to five years of research experience or training in an Academic Medical Center.
Experience with databases and/or patient data.
Experience with cooperative group trials, particular preference given to NCTN/ECTCN or other cancer relevant clinical trial networks/groups.
Demonstrated understanding of Good Clinical Practice.
Foundational understanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subject clinical trials.
Clinical research or trials coordination experience, as well as foundational understanding of oncological and clinical research concepts and terminology.
Professional certification in clinical research (through SOCRA or ACRP).
Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills.
Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, UFHCC staff, and others.
Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capability.
Demonstrated understanding and effective use of Emotional Intelligence strategies and skills.
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues.
Proficient meeting management, group facilitation, and presentation skills.
Project manager mindset and basic skills including: delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility.
Proficiency using the Microsoft Office suite.
Special Instructions to Applicants:
The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Applicants must upload a copy of the following documents to be considered for this position:
Cover Letter or Letter of Interest
Curriculum Vitae or Resume
List of Three Professional References
This is a time limited position.
Application must be submitted by11:55 p.m. (ET)of the posting end date.
Health Assessment Required:No.
Advertised: 15 Feb 2023 Eastern Standard Time
Applications close: 01 Mar 2023 Eastern Standard Time