Clinical Research Coordinator, Oncology in Schenectady , New York at Ellis Medicine

Our Day ONE benefits package is more than competitive, offering health and wellness, dental, vision, AND tuition reimbursement. Join our team and GROW with Ellis!

The Clinical Research Associate works collaboratively under the direction of the Director, Oncology Services and with the Service Line Physicians as the communication link between study sponsors, investigators and institutional officials. The Clinical Research Coordinator serves as a resource for federal and local regulations regarding the conduct of research; coordinates contractual issues related to projects.

EDUCATION AND EXPERIENCE REQUIREMENTS:

Graduate of accredited RN program with current licensure and registration in NYS with Bachelors’ degree in healthcare related field. Master’s Degree Preferred. Valid NYS licensure as a Registered Professional Nurse. Or, Bachelor’s Degree in Clinical Research with at least 1 year experience in clinical research or other related experience.

Experience: In addition to clinical experience or experience with clinical research, incumbent must have the following:

• Proficient computer skills including Excel, Word and other Microsoft Office Programs. Capability to adapt to multiple data entry systems and excellent data collection and chart abstraction skills
• Knowledge of Good Clinical Practice (GCP), scientific principles and research methodology
• Familiarity with Research Regulations and precise record keeping meeting FDA requirements
• Ability to work autonomously and collaborate directly with Principle Investigators, Sub-Investigators, Study Sponsors
• Maintain accurate records for management of research budgets and invoicing
• Capability of managing multiple priorities in a deadline-driven environment
• Demonstrate exceptional customer/patient-focused service
• Commitment to professional and accurate written and verbal communications
• Must work on-campus directly with prospective and study participants

GUIDING BEHAVIORS:

• Communication: Listen to understand, before seeking to be understood.
• Collaboration: Deliver outstanding service ensuring that safety comes first.
• Compassion: Serve every person with empathy, dignity, and compassion.

PHYSICAL REQUIREMENTS

• Should be able to push/pull, lift/move 35 lb., be able to perform moderately difficult manual manipulations such as using a keyboard, writing, and filing for extended periods of time, must be able to perform tasks which require hand-eye coordination such as data entry, typing and using photo copiers. Mobility requirements may include the ability to be stationary at a workstation for a prolonged period time in addition to being able to squat or be mobile for a reasonable length of time and distance. Communication requirements include the ability to comprehend the spoken English language in addition to being able to communicate and read the English language.

RESPONSIBILITIES OF THE POSITION:

• Compliance with FDA and other Regulatory Agencies
• Follows study protocols, monitors for deviations or adverse events and appropriately investigates and reports any variation to PI and/or Sub-Investigator, Study Sponsor, IRB and any other parties requiring notification
• Works directly with PI/Sub-I and Sponsor for study design and implementation and facilitates all aspects of study design including assessment of feasibility and management of protocols
• Screens, enrolls and recruits research patients under the direct supervision of the PI. Monitors subject participation
• Prepares study submissions for the IRB and attends and participates in IRB meetings
• Maintains Patient Rights and Privacy
• Coordinates schedules, meetings and on-site visits
• Maintains accurate records for study participants
• Prepares study documentation for auditing purposes or FDA site visits
• Identifies performance improvement opportunities and program growth opportunities for Research Program and implements process or program changes to further develop the program
• Provides education and training to Oncology staff
• Maintains research-related policies and procedures and applies organizational policies to study protocols
• Performs administrative and regulatory duties as appropriate

Work Quality:

• Documents all study related tasks in timely and accurately and maintains participant records for auditing purposes
• Performs duties in an accurate and organized manner, collaborates regularly with provider staff related to study protocols
• Completes duties within appropriate timeframes, prioritizes tasks and manages time-sensitive timelines
• Performs in accordance with the facility’s policies and procedures and regulatory standards
• Recognizes patients’ rights and responsibilities and advocates for patients and study participants

Ellis Medicine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex/gender, age, national origin, disability, genetic information, predisposition or carrier status, military or veteran status, prior arrest, or conviction record, marital or familial status, sexual orientation, transgender status, gender identity, gender expression, reproductive health decisions, or domestic violence victim status.

Salary Range: $29.44-$44.16/hour Pay is based on experience, skills, and education. Exempt positions under the Fair Labor Standards Act (FLSA) will be paid within the base salary equivalent of the stated hourly rates. The pay range may also vary within the stated range based on location.