Clinical Research Manager

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Company: Regional Cancer Care Associates LLC

Location: Belleville, NJ 07109

Description:

Job Type

Full-time

Description

Regional Cancer Care Associates (RCCA) is looking for an exceptional Clinical Research Manager to join the team. This position manages clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives.

ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures(SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include Code of Ethics and Business Standards.

This individual must also possess strong multi-tasking abilities and bring positivity and passion to their work. If you want to join a team that is on the cutting edge of cancer care, while always putting the patient first, we want to hear from you!

Employment Type: Full Time

Location: Belleville, NJ

As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.

We believe these benefits underscore our commitment to the well-being and professional growth of our employees.

Key Responsibilities:
  • Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. Responsible for
  • ensuring at the administrative level that all research activities are coordinated with affected departments within the practice.
  • Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance,
  • recommending salary changes, and progressive discipline. Enforces adherence to company policies.
  • Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action
  • plans designed to improve practice research operations and quality assurance functions.
  • Collaborates with practice management staff in the development and implementation of research budget that includes accrual
  • targets and financial objectives. Develops accountability standard to ensure that targets and budgets are achieved.
  • Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program.
  • Responsible to promote or market research program to the practice, community and referring physicians.
  • Responsible for coordinating research activities with other (non-USOR) bases or sponsors.


Requirements

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

Education/Training:
  • Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred.


Business Experience:
  • Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology
  • Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred
  • If required for state of practice, current licensure as a registered nurse (RN)
  • SoCRA or ARCP certification preferred


Specialized Knowledge/Skills:
  • Excellent communication skills, strong ability to multitask
  • Strong interpersonal skills
  • Must be able to work in a fast paced constantly changing environment
  • Knowledge and proficiency in all basic computer programs, windows, excel etc.
  • Special knowledge of GCP and ICH guidelines
  • Specific knowledge of all aspects of clinical research - ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions
  • Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails
  • Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle


Working Conditions:
  • Traditional office environment
  • The work environment characteristics described here are representative of those an employee encounters 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 common to an oncology/hematology clinic environment.


Physical Requirements (Lifting, standing, etc.) -
  • Large percent of time performing computer based work is required.
  • 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 full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination.
  • Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
  • (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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