Clinical Research Assistant-Oncology

Do you want to make a difference in healthcare and have a commitment to learning Do you thrive on a dynamic team and value collaboration communication and teamwork If you are looking to increase your skills and knowledge and contribute we want to speak to you about our Clinical Research Assistant position.

WHAT WILL YOU DO AS A CLINICAL RESEARCH ASSISTANT IN OUR MEDICAL ONCOLOGY DEPARTMENT

The Clinical Research Assistant works collaboratively with the Clinical Research Coordinator and Principal Investigator (PI) or Sub PI 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. With Clinical Research Coordinator the Clinical Research Assistant serves as a resource for federal and local regulations regarding the conduct of research; coordinates contractual issues related to projects.

RESPONSIBILITIES OF THE POSITION:

• Review regulatory documents and assist in drafting study protocols informed consent forms (ICFs) and case report forms (CRFs) to ensure compliance with FDA ICHGCP and IRB guidelines.
• Coordinate multisite research activities remotely and inperson maintaining effective communication with investigators sponsors and regulatory authorities to support study execution and regulatory compliance.
• Conduct systematic literature reviews and synthesize findings to inform grant writing manuscript preparation and clinical study design.
• Develop and implement remote monitoring strategies to track study progress verify protocol adherence and ensure timely and accurate data entry.
• Collaborate with crossfunctional research teams to resolve data discrepancies and maintain study integrity.
• Support the preparation of regulatory submissions study reports and other studyrelated documentation.
• Assist in identifying potential compliance risks and propose corrective actions as needed.
• Maintains Patient Rights and Privacy

Under the direct supervisor of the Clinical Research Coordinator:

• Follows study protocols monitors for deviations or adverse events and appropriately investigates and reports any variation to PI and/or SubInvestigator Study Sponsor IRB and any other parties requiring notification
• Works directly with PI/SubI 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
• Coordinates schedules meetings and onsite 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 as it relates to study protocols
• Performs administrative and regulatory duties as appropriate
• Works with Oncology Leadership on other researchrelated project or program implementation
• Other duties as assigned

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 timesensitive timelines
• Performs in accordance with the facilitys policies and procedures and regulatory standards
• Recognizes patients rights and responsibilities and advocates for patients and study participants

WHAT DO YOU NEED TO BE A CLINICAL RESEARCH ASSTANT

EDUCATION AND EXPERIENCE REQUIREMENTS:

High school diploma with relevant experience or education in a healthrelated field.

Ability to work oncampus directly with prospective and study participants and remote work as assigned by the Clinical Research Coordinator PI SubPI or Director of Oncology Services.

Preferred Familiarity with:

• Computer applications including Excel Word and other Microsoft Office Programs.
• Data entry systems data collection and data abstraction
• Awareness of research regulatory practices i.e. Good Clinical Practice (GCP) scientific principles and research methodology
• Research Regulations and precise record keeping meeting FDA requirements
• Autonomous work and collaboration with Principal Investigators SubInvestigators Study Sponsors and members of the team
• Maintaining accurate records for management of research budgets and invoicing
• Managing multiple priorities in a deadlinedriven environment
• Exceptional customer/patientfocused service
• Professional and accurate written and verbal communications

PHYSICAL REQUIREMENTS

The position is located indoors under normal working conditions. Should be able to push/pull 25 lb. lift/move 15 lb. from floor to table be able to perform moderately difficult manual manipulations such as using a keyboard writing and filing must be able to perform tasks which require handeye coordination such as data entry typing and using photo copiers. Mobility requirements may include the ability to sit at a computer terminal or workstation for a prolonged period of time in addition to being able to squat stand and walk for a reasonable length of time and distance. Sensory requirements include the ability to articulate and comprehend the spoken English language in addition to being able to read the English language.

Ellis Medicine is committed to creating a diverse environment and is proud to be an equalopportunity 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: $22.28$32.31 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.