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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, ICH-GCP, and IRB guidelines.

+ Coordinate multi-site research activities remotely and in-person, 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 cross-functional research teams to resolve data discrepancies and maintain study integrity.

+ Support the preparation of regulatory submissions, study reports, and other study-related 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 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

+ 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 as it relates to study protocols

+ Performs administrative and regulatory duties as appropriate

+ Works with Oncology Leadership on other research-related 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 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

WHAT DO YOU NEED TO BE A CLINICAL RESEARCH ASSTANT?

EDUCATION AND EXPERIENCE REQUIREMENTS:

High school diploma with relevant experience or education in a health-related field.

Ability to work on-campus directly with prospective and study participants and remote work as assigned by the Clinical Research Coordinator, PI, Sub-PI 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, Sub-Investigators, Study Sponsors and members of the team

+ Maintaining accurate records for management of research budgets and invoicing

+ Managing multiple priorities in a deadline-driven environment

+ Exceptional customer/patient-focused 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 hand-eye 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 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: $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.