Role Description This full-time remote Clinical Research Associate (CRA) role at MDCE CRO is responsible for monitoring clinical trial sites to ensure studies are conducted in accordance with protocols, Good Clinical Practice (GCP), and regulatory requirements. The CRA will perform routine on-site and remote monitoring visits, including source data verification, review of essential documents, and assessment of site compliance and performance. Daily activities include communicating with site staff and sponsors, tracking study progress, resolving data queries, and documenting findings in monitoring reports and trial management systems. The role also involves supporting site start-up and close-out activities, training site personnel on study procedures, and collaborating with cross-functional teams to address operational issues. The CRA is expected to manage multiple studies or sites, prioritize tasks effectively, and maintain high-quality standards and timelines. Qualifications
Demonstrated understanding of clinical trial protocols and the ability to interpret and apply protocol requirements consistently.
Experience working as a Clinical Research Associate or in a similar clinical research role, with responsibility for site monitoring and oversight.
Knowledge of clinical trials processes, including study start-up, conduct, and close-out, as well as familiarity with ICH-GCP and relevant regulatory guidelines.
Background in clinical operations, including site management, documentation, and coordination with sponsors and investigative sites.
Strong research skills, including data review, critical thinking, and attention to detail in identifying and resolving issues.
Bachelor’s degree in life sciences, nursing, pharmacy, or a related field; an advanced degree or professional certification in clinical research is an advantage.
Excellent written and verbal communication skills, with the ability to work effectively with diverse site and sponsor teams.
Proficiency with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and standard office software.
Ability to work independently in a remote setting, manage time efficiently, and travel to sites as required.
Prior experience in a CRO or pharmaceutical environment and exposure to multiple therapeutic areas is beneficial.