Responsible for specific clinical/scientific activities on a single study or across multi e studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials).
Support development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables).
May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives.
Support development of site and CRA training materials
Prepare clinical narratives
Collaborate cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity of trial conduct.
Participate in CRF design to ensures data collection is in alignment with the protocol.

Requirements

Bachelor's Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
Degree in life sciences, preferred.
Working knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Ability to manage multi e competing priorities with good planning, time management and prioritization skills
Analytical skills with the ability to interpret clinical trial data and synthesize conclusions
Interact with key stakeholders across department, division, and company.

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical monitoringlab specimen trackingdata managementclinical narratives preparationCRF designprotocol developmentICF documentsdata analysisproject management

Soft Skills

planningtime managementprioritizationanalytical skillscommunicationcollaboration