Date Posted:
2025-07-29
Country:
United States of America
Location:
Florida - Remote
WHY JOIN FCS
At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communities we serve, associates benefit from significant professional opportunities, career advancement, training and competitive wages.
Offering competitive salaries and comprehensive benefits packages to include tuition reimbursement, 401-K match, pet and legal insurance.
A LITTLE BIT ABOUT FCS
Since 1984, Florida Cancer Specialists & Research Institute & Research Institute (FCS) has built a national reputation for excellence. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations in our network. Utilizing innovative clinical research, cutting-edge technologies, and advanced treatments, we are committed to providing world-class cancer care. We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. Our patients have access to ground-breaking therapies, in a community setting, and may participate in national clinical research studies of drugs and treatment protocols. In the past five years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation prior to approval.
Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States. Often, FCS leads the nation in initiating research studies and offering ground-breaking new therapies to patients.
Come join us today!
Summary:
FLORIDA RESIDENT CANDIDATES ONLY
Supports clinical research quality/improvement and training activities at Florida Cancer Specialists (FCS). Demonstrates working knowledge of all facets of the role; relevant regulations; and organizational, and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.
PRIMARY TASKS AND RESPONSIBILITIES:
Assists in developing and providing training for staff and investigators in a thorough and comprehensive manner according to the individual’s role.
Provides support in development, review and revisions of Standard Operating Procedures (SOP) and Work Instruction (WI’s), ensuring that SOPs and WIs are aligned with each other, GCP, local and federal regulations.
May work with the Compliance team to ensure SOPs are uploaded and assigned to research staff members and ensures training compliance with the SOPs.
Ensures training on SOP and WIs is completed within 30 days of publication; follows up with staff as needed.
Ensures staff are compliant with SOPs and escalates issues of research noncompliance to research management/leadership.
Reviews and investigates deviations. Reports on trends.
Acts as a resource for staff and business partners for quality-related questions, issues, or concerns.
Represents research by actively participating in organization and departmental quality activities and initiatives, committees, working groups, or other.
Track findings from monitoring visits - deviations, action items
Assist teams with completion of those tasks (reporting of deviations, completion of action items)
Report on any trends to the Manager/Sr. Manager/Director
Support the training department with training topics to ensure adequate training is provided to all research sites
Manage the Quality SharePoint site for audit-related activities and documents; monitor related activities and documents
Supports audit/inspection activity by ensuring requirements are met and that the site PI and other staff are prepared for inspections or audits.
Additional tasks as needed to support team and FCS
EDUCATION/CERTIFICATIONS & LICENSES:
Bachelor’s degree, required
Valid state Driver’s License for travel to satellite offices and offsite meetings.
EXPERIENCE:
Four (4) years of clinical research experience and two (2) years of oncology experience required.
Minimum of 3+ years of previous Quality Assurance/clinical research experience in clinical research, preferred.
Experience with preparation and hosting of external audits and FDA inspections, preferred.
Knowledge of relevant regulations and guidelines including 21 CFR 812; 21 CFR 312;1CFR Part 11 and ICH GCP.
CORE COMPETENCIES, KNOWLEDGE/SKILLS/ABILITIES:
Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
Leadership and Mentoring: Effectively lead and facilitate a team, including group discussions, coach, mentor, motivate, and engage others to align to a common goal. Ability to effectively lead projects from inception through implementation and assessment. Ability to complete tasks unsupervised.
Human Resources Management: Coach and support staff development, as applicable, as well as manage resources, performance and employee relations, and supervise within established policies, procedures and legislation.
Computer programs: Experience with Microsoft Office applications, Clinical Trial Management Systems (CTMS), Electronic Medical Record systems (EMR)
VALUES:
Patient First – Keeping the patient at the center of everything we do
Accountability – Taking responsibility for our actions
Commitment & Care – Upholding FCS vision through every action
Team – Working together, one team, one mission
Expectations for all Employees
Every FCS employee is expected to regularly conduct themselves in a professional and respectful manner, to comply with all labor laws, workplace policy and workplace practices. Employees are expected to bring issues of any forms of workplace harassment, discrimination or other potential improprieties to the attention of their management or the human resources department.
#FCS-RX
#LI-DL1
SCREENINGS – Background, drug, and nicotine screens
Safeguarding our patients and each other is an important part of how we deliver the best care possible to the communities we serve. All offers of employment at Florida Cancer Specialists & Research Institute are contingent upon clear results of a thorough background screening. Additionally, as a condition of employment, FCS requires all new hires to receive various vaccinations, including the influenza vaccine, barring an approved exemption. In addition, FCS is a drug-free workplace, and all new hires will be subject to drug/ nicotine testing. Medical Marijuana cards are not recognized.
EEOC
Florida Cancer Specialists & Research Institute (FCS) is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at FCS, please email FCS Recruitment (Recruiter@FLCancer.com) for further assistance. Please note this email address is intended to request an accommodation as part of the application process. Any other correspondence will not receive a response.
FCS is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
