Clinical Research Team Leader

2 weeks ago

Ocala, Florida, United States Florida Cancer Affiliates Full time

Position Overview:
Florida Cancer Affiliates/Ocala Oncology is seeking a full-time Clinical Research Team Leader for our Ocala location.

Why join our team? We provide our employees with a comprehensive benefits package that includes Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability coverage, a generous Paid Time Off (PTO) program, a 401k plan with company matching, a Wellness initiative that incentivizes healthy living, and various other benefits such as Tuition Reimbursement, an Employee Assistance program, and discounts at popular retailers.

This exempt management role involves overseeing and facilitating oncology clinical trials for a community oncology group that is at the forefront of phase 1 through phase 3 studies in Florida.

The Clinical Research Team Leader supervises the clinical research personnel in alignment with USON Standard Operating Procedures (SOP) and International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines. This role is responsible for ensuring that all research activities are effectively coordinated with relevant departments within the practice at the administrative level. The position includes coaching and developing staff, collaborating on the establishment of research accountability standards, and identifying opportunities for enhancement. It is essential to ensure research quality by adhering to the US Oncology Research, Inc. (USOR) SOP, GCP principles, and applicable federal, state, and local regulations. The role also supports and complies with the US Oncology Compliance Program, including the Code of Ethics and Business Standards.

Key Responsibilities:
Supervise clinical research staff in accordance with USOR SOP and ICH GCP guidelines. Ensure that all research activities are coordinated with relevant departments within the practice at the administrative level. Coach and develop team members. Participate in recruitment, interviewing, hiring, performance assessment, recommending salary adjustments, and managing progressive discipline. Enforce adherence to company policies. Collaborate in the development of research accountability standards, metrics, and reports, and identify areas for improvement.

Work alongside the site research leader (SRL), upper management, and staff to implement action plans aimed at enhancing research operations and quality assurance functions.

Collaborate with the SRL, physicians, and other research management to select studies for the research program.

Work with the SRL and upper management on developing research budgets, financial objectives, and accrual targets. May promote or market the research program to the practice, community, and referring physicians. May coordinate research activities with other bases or sponsors.

Qualifications:
Minimum Job Requirements:

Qualifications:

A Master's or PhD is advantageous; an Associate's degree in a clinical or scientific discipline is required. Graduation from an accredited nursing program is preferred. Business acumen, a personable demeanor, and the ability to work collaboratively are essential in this role.

A minimum of 5 years of clinical nursing experience or experience in a scientific discipline is required, preferably in oncology. Supervisory experience is preferred, along with experience in clinical research. If required in the state of practice, current licensure as a registered nurse (RN) is necessary. Current Basic Life Support (BCLS) or Advanced Cardiovascular Life Support (ACLS) certification for nurses is required. SoCRA or ARCP certification is preferred. Specialized Knowledge/Skills include excellent communication skills, strong multitasking abilities, and strong interpersonal skills. Must be able to thrive in a fast-paced, constantly evolving environment. Proficiency in basic computer programs, including Windows and Excel, is required.

Familiarity with GCP and ICH guidelines is preferred. Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, and oncology as they relate to clinical trials is essential.

Working Conditions:
Environment: Traditional office setting.

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations, and other conditions typical of an oncology/hematology clinic environment may occur.
Physical Requirements:
  • A significant portion of time will be spent performing computer-based tasks.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires a full range of body motion, including handling and lifting patients, manual dexterity, and eye-hand coordination. Requires standing and walking for extended periods. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing within normal ranges. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)

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