Regional Clinical Research Associate - Remote/Travel

Syneos Health, Inc.; Montana; Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Syneos Health is seeking an Experienced Clinical Research Associate to support regionally across the US, including Montana. The role involves site qualification, initiation, monitoring, data integrity, and collaboration with site staff to ensure ICH-GCP and protocol adherence.

The CRA will travel up to 75% to manage sites, conduct source data verification, and support trial conduct. Strong communication and problem-solving skills are essential for success in a fast-paced environment.

Qualifikationen

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Aufgaben

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent and protects confidentiality while assessing safety and data integrity at investigator sites.
• Per CMP/SMP: Assesses site processes, conducts source document review, ensures CRF data accuracy and timeliness.
• May perform IP inventory, reconciliation, and reviews storage and security; ensures proper labeling and release/return.
• Routinely reviews the Investigator Site File (ISF) for accuracy and archiving requirements.
• Documents activities and supports recruitment, retention and tracking of observations and actions.
• Supports site-level activity management to meet project objectives and timelines.
• Acts as liaison with study site personnel and trains site team members as needed.
• Prepares for Investigator Meetings and sponsor meetings; participates in global monitoring meetings.

Kenntnisse

Excellent communication

Good computer skills

Travel up to 75%

Ausbildung

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

Jobbeschreibung

Syneos Health is seeking an Experienced Clinical Research Associate to support regionally across the US, including Montana. The role involves site qualification, initiation, monitoring, data integrity, and collaboration with site staff to ensure ICH-GCP and protocol adherence.

The CRA will travel up to 75% to manage sites, conduct source data verification, and support trial conduct. Strong communication and problem-solving skills are essential for success in a fast-paced environment.