Assist in the collection, cleaning, and validation of clinical trial data from various sources. Perform data entry and data review activities to ensure quality and integrity. Support database setup, testing, and maintenance activities. Track and manage queries related to data inconsistencies and work with clinical sites to resolve them. Maintain documentation in compliance with Good Clinical Practice (GCP) and standard operating procedures (SOPs). Collaborate with cross-functional teams including clinical operations, biostatistics, and medical writing. Support the preparation of data management reports and metrics. Participate in team meetings, training sessions, and project discussions.
Assist in site selection, initiation, monitoring, and close-out visits. Ensure that clinical trials are conducted in accordance with protocols, SOPs, GCP, and regulatory requirements. Verify the accuracy and completeness of case report forms (CRFs) and source documents. Maintain essential documents in the Trial Master File (TMF). Assist in resolving data queries and discrepancies with the site staff. Support investigators and site staff in trial-related activities. Participate in project team meetings and training sessions. Prepare visit reports and follow-up letters. Maintain regular communication with study sites to ensure compliance and timely data entry.
Receive, triage, and process individual case safety reports (ICSRs). Enter event data into PV databases accurately and in compliance with timelines. Code medical terms using MedDRA / WHO-DD. Assess seriousness, causality, and expectedness of cases. Conduct literature surveillance to identify potential safety signals. Assist in preparing case narratives, reports, and documentation. Support creation of aggregate safety reports (e.g., PSURs, RMPs). Ensure adherence to SOPs and regulatory standards. Bachelors or Masters in Pharmacy, Life Sciences, Biotechnology, or related field. Excellent attention to detail and analytical capabilities. Basic understanding of medical terminology and drug safety processes.
Assist in reviewing medical records and documentation for accuracy and completeness. Learn to assign appropriate ICD-10, CPT, and HCPCS codes under supervision. Support the coding team in maintaining compliance with healthcare regulations and guidelines. Participate in training programs and workshops to build coding knowledge and skills. Ensure confidentiality and security of patient health information. Collaborate with senior coders, auditors, and healthcare staff to clarify documentation. Maintain productivity and quality standards as per organizational requirements.
Assist in site selection, initiation, monitoring, and close-out visits under supervision. Ensure that clinical trials are conducted in accordance with ICH-GCP guidelines, SOPs, and regulatory requirements. Verify accuracy, completeness, and consistency of Case Report Forms (CRFs) and other study documentation. Support in maintaining essential clinical trial documents and trial master files. Collaborate with investigators, site staff, and project teams to ensure smooth trial operations. Assist in reporting adverse events and ensuring patient safety compliance. Participate in training programs and workshops to build technical knowledge and monitoring skills.