Job Description

Clinical Research Assistant or Clinical Research Coordinator

Must Haves: Must have phase 1 Oncology experience and some clinical research experience

Hours: 40 hours per week, Monday-Friday, onsite, normal business hours. Need someone flexible to come in earlier or stay later for patient needs.

Contract Duration: Permanent position

Benefits: Medical, Dental, Vision, time off, paid holidays off, bonus. 401k, growth opportunities, etc.

Purpose

Coordinate and manage complex activities throughout the start-up, conduct, and close-out phases of clinical pharmaceutical and device research studies. Ensure timely, accurate, and objective data collection in compliance with companies Research SOPs, federal regulations, GCP, ICH guidelines, IRB requirements, and specific sponsor protocols. All work should align with company Research’s Core Values, Mission Statement, and Employee Manual.

Key Responsibilities

• Thoroughly understand assigned protocols and ensure all patient visits and procedures are completed as specified.
• Accurately document patient assessments, observations, test results, and other study-related data following federal regulations and protocol requirements.
• Obtain informed consent from patients in compliance with federal regulations, GCP, and IRB requirements.
• Strategically recruit eligible study subjects to meet enrollment targets within sponsor timelines while upholding ethical and regulatory standards.
• Complete required training promptly.
• Schedule and conduct patient visits in line with protocol timelines.
• Maintain complete and precise source documentation for all study activities.
• Accurately complete and submit case report forms (CRFs/eCRFs) and sponsor worksheets.
• Safeguard the confidentiality of patient and study information in accordance with HIPAA, confidentiality agreements, and company policies.
• Promptly report adverse events to the supervisor and/or Principal Investigator/Sub-Investigator as appropriate.
• Notify the sponsor of Serious Adverse Events (SAEs) within 24 hours of awareness and inform the supervisor and Principal Investigator/Sub-Investigator.
• Manage and track study materials (e.g., study drug, CRFs, lab supplies) to ensure availability throughout the study.
• Maintain consistent communication and document interactions with the Team Lead I, Team Manager, Principal Investigator, Sub-Investigators, and other research staff.
• Participate in required training, conferences, and investigator meetings to remain current with evolving federal regulations and company policies.
• Continuously seek educational opportunities to deepen knowledge of clinical research processes and regulations.
• Perform study-related tasks efficiently and cost-effectively, always adhering to company policies.
• Follow safety procedures in all activities.
• Represent company Research professionally and courteously in all interactions—verbally, in writing, and in appearance—with patients, staff, sponsors, and external partners.
• Carry out additional duties as assigned by management.

Physical & Environmental Requirements

• Primarily office-based work environment.
• Exposure to human bodily fluids and lab processing.
• Direct patient care responsibilities.
• Daily use of computers.
• Occasional evening and weekend work.
• Ability to lift up to 35 pounds, occasionally more.
• Must have a valid driver’s license and daily access to a car.

Minimum Requirements

Education:

• Bachelor’s degree preferred, but not required.

Experience:

• Ideally, at least 1 years in Clinical Research
• Oncology experience and experience with phase 1 trials is a plus

Skills & Knowledge:

• Solid understanding of clinical research methodologies.
• Strong leadership and team management capabilities.
• Effective collaboration with operational teams.
• Excellent verbal and written communication.
• Proficiency in Office 365 and other relevant software.
• Experience drafting and reviewing Standard Operating Procedures.
• Strong problem-solving, risk assessment, and analytical skills.
• Demonstrated process improvement experience.
• Effective negotiation and conflict resolution skills.
• Ability to multitask, prioritize tasks, and remain flexible.
• Independent thinker able to influence and drive decisions when needed.

Apply Today!

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