Job Description

Job Description

Job Description

Summary: The Research Assistant I (RA I) is an entry-level position responsible for providing fundamental support to clinical research teams. Under direct supervision, the RA I assists with study documentation, data collection, regulatory compliance, and participant coordination. This role is designed for individuals looking to develop foundational research skills and gain exposure to clinical trial operations.

Duties and Responsibilities: The Research Assistant I

• Assists in organizing and maintaining study records, including regulatory binders, training logs, and informed consent forms (ICFs).
• Supports data entry and document organization to ensure compliance with research protocols.
• Tracks study-related materials, supplies, and laboratory kits.
• Assists in preparing and filing study-related correspondence.
• Stocks and organizes supplies in research rooms.
• Cleans and maintains research rooms at the end of the day.
• Learns and adheres to Good Clinical Practice (GCP) and FDA regulatory guidelines.
• Assists in the collection and submission of essential regulatory documents.
• Supports study teams in ensuring research protocols comply with institutional and sponsor requirements.
• Supports audit preparation by organizing study documentation.
• Assists with participant scheduling, visit coordination, and follow-up communication.
• Observes the informed consent process and supports documentation of participant interactions.
• Tracks subject enrollment and maintains recruitment logs.
• Makes reminder calls and texts to participants, providing backup for the front desk.
• Covers front desk operations as needed.
• Orders food for study participants as required.
• Conducts vital sign measurements and ECGs under supervision.
• Ensures confidentiality and ethical handling of study participant information.
• Assists in entering, reviewing, and organizing clinical trial data.
• Supports data verification and quality control measures to ensure accuracy.
• Learns to use electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Assists with identifying and resolving basic data queries under supervision.
• Provides general administrative support for research teams.
• Assists with general administrative tasks, including meeting scheduling and documentation.
• Collaborates with research teams to maintain effective study workflows.
• Participates in research training and continuing education activities as required.
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required.
• Performs other miscellaneous job-related duties as assigned by their manager.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

• High school diploma or equivalent required.
• Associate or bachelor’s degree in a health-related field (Nursing, Biology, Public Health, or related discipline) preferred.
• Exposure to clinical or healthcare settings is a plus.
• Basic proficiency in Microsoft Office (Word, Excel, Outlook).
• Willingness to learn Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• IATA (dangerous goods handling) – Must renew every 2 years
• OSHA trainings

Competency Requirements:

• Strong attention to detail and accuracy in documentation.
• Ability to organize and prioritize tasks efficiently.
• Effective communication skills and ability to work within a team.
• Willingness to learn and develop research-related skills.
• Ability to handle confidential information with discretion.
• Interest in clinical research and regulatory compliance.

Physical Requirements and Environmental Factors:

• Travel may be required.
• Night/weekend work schedules
• Work is normally performed in a typical interior clinical/office environment.
• Prolonged periods of sitting at a desk and working on a computer.
• Lifting of 20 pounds and occasionally more than 20 pounds.

Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

Job Tags

Similar Jobs