Senior Clinical Research Associate - Site Management

Syneos Health/ inVentiv Health Commercial LLC

Billings (MT)

Sur place

USD 70 000 - 100 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Company car or car allowance
Health benefits (medical, dental, etc)
401(k) with match
Employee Stock Purchase Plan
Flexible PTO and sick time

Résumé du poste

Syneos Health is seeking an Experienced Clinical Research Associate - Sponsor Dedicated to work across site qualification, initiation, monitoring and close-out activities. You will ensure regulatory and protocol compliance, perform source data review, and support data integrity across trials.

The role requires travel up to 75% and excellent communication, with a focus on patient safety and data quality. You will collaborate with cross-functional teams and contribute to audit readiness and

Qualifications

  • 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 up to 75% on a regular basis.
  • US ONLY: Employment privacy notice may require sharing information for site access.

Responsabilités

  • Performs site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote) with regulatory and protocol compliance.
  • Verifies informed consent processes and protects subject confidentiality.
  • Conducts Source Document Review and CRF data verification; supports query resolution.
  • Manages IP inventory, labeling, storage, and reconciliation per protocol.
  • Maintains ISF accuracy and TMF reconciliation; ensures archiving per guidelines.
  • Supports subject recruitment and data tracking; communicates project status and timelines.
  • Attends Investigator Meetings and sponsor meetings; trains site staff as needed.
  • Guides audit readiness activities and prepares for inspections.

Connaissances

Clinical monitoring
Regulatory compliance
Communication skills
Travel readiness
GCP knowledge

Formation

Bachelor's degree or RN

Outils

Electronic data capture (EDC)
ISF/TMF management

Description du poste

Syneos Health is seeking an Experienced Clinical Research Associate - Sponsor Dedicated to work across site qualification, initiation, monitoring and close-out activities. You will ensure regulatory and protocol compliance, perform source data review, and support data integrity across trials.

The role requires travel up to 75% and excellent communication, with a focus on patient safety and data quality. You will collaborate with cross-functional teams and contribute to audit readiness and

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