Clinical Research Associate (West Coast)

ProPharma • Raleigh, NC

76d

About The Position

The Clinical Research Associate position is responsible for clinical monitoring for assigned protocols and investigational sites as well as ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements.

Requirements

• Bachelor's degree or equivalent combination of education and experience.
• 4 years of experience as a Clinical Research Associate.
• Excellent verbal, written communication skills and interpersonal and presentation skills.
• Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point).
• Electronic data capture (EDC), CTMS, IVRS, and eTMF experience.
• Knowledge of applicable regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Strong organizational skills and attention to details.

Nice To Haves

• Targeting those on the west coast with IVD therapeutic experience.
• Ability to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.

Responsibilities

• Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote.
• Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.
• Supports development of study specific documentation related to monitoring activities as assigned.
• Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements.
• Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
• Managing, preparing, sending, tracking, and returning investigational supplies as assigned.
• Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements.
• Responsible for review and oversight of regulatory documentations for accuracy, completeness, and supporting assigned clinical sites with any regulatory concerns as appropriate.
• Responsible for consistent and timely communication with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials.
• Participates in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees