Job Description

Job Profile Summary: This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills.

Responsibilities:

• EDC Entry and Query Resolution
• Develop strong working relationships and maintain effective communication with study team members.
• Develop strong working relationships with the investigators and office staff to build a foundation of trust and respect between the clinic and the research office.
• Assist with the screening, recruiting, and enrollment of research subjects.
• Perform patient/research participant scheduling.
• Collect patient/research participant history.
• Coordinate follow-up care and laboratory procedures.
• Adhere to an IRB-approved protocol.
• Assist in the informed consent process of research subjects.
• Support the safety of research subjects.
• Coordinate protocol-related research procedures, study visits, and follow-up care.
• Comply with company and Sponsor policies, standard operating procedures (SOPs), and guidelines.
• Schedule subject visits and procedures.

Qualifications:

• Equivalent education and experience - High School Diploma and 1 year of relevant work experience in clinical research.
• At least 1 year experience working in a clinical research setting preferred.
• Working knowledge of clinical trials.
• Working knowledge of the principles of Good Clinical Practices (GCP).
• In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules.
• Skill in carrying out required clinical procedures.
• Working knowledge of medical terminology.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients.
• Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies.

Please note, this position is not eligible for sponsorship.

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