Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The minimum annualized starting base pay for a level I position is 113,000 PLN and for level II position it is 143,000 PLN.
Responsibilities
Forecast submission/approval timelines and ensures they are adhered to.
Prepare and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
Assists with EC/IRB or CA issue resolution at the country level.
Prepare ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules.
Perform essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
Requirements
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional.
The Senior Clinical Research Associate delivers quality monitoring reports and ensures data integrity and subject safety in accordance with ICH GCP/ISO14155 and regulations.
Compensation
This is a full-time contract position for 12 months.
Responsibilities
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines
Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
Monitors (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations
Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP
Requirements
Undergraduate degree or its international equivalent in clinical, science, or health-related field
licensed health-care professional (i.e., registered nurse)
Responsible for monitoring clinical trials, ensuring data integrity, patient safety, and compliance with regulatory standards across multiple sites.
Responsibilities
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
Maintains submission of expenses according to travel and expense requirements within company guidelines
Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
Plans day-to-day activities for monitoring a clinical study and sets priorities per site
Requirements
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution
Licensed health-care professional (i.e., registered nurse)
Conducts all monitoring visit types (qualification, initiation, interim, close-out; remote/onsite) per the Clinical Monitoring Plan, ensuring data integrity, patient safety, and quality/timeliness of deliverables and reports, while planning and prioritizing day-to-day site activities.
Locations (3)
West Coast, United States
Midwest, United States
Northeast, United States
Compensation
The annualized minimum base pay for this role is $80,000 USD.
Responsibilities
Conducts all monitoring visit types (qualification, initiation, interim, close-out) per the Clinical Monitoring Plan
Ensures validity, correctness, and completeness of clinical data per ICH GCP/ISO14155, protocol, and client requirements
Maintains TMF/eTMF per ICH/GCP Appendix C and organizational filing guidelines
Manages communication with study sites, project teams, and management
Handles administrative responsibilities: timely expense submission, time/hours entry, project tracking, site visit metrics, and confidentiality/compliance with global and local laws
Requirements
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution
Licensed health-care professional (i.e., registered nurse)