Research Associate

Job Purpose:

Coordinate and participate in clinical research studies conducted by principal investigator(s). Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.

Job Responsibilities:

Clinical:

• Coordinate and participate in clinical research studies conducted by principal investigator(s) ; coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Assist in the determination of guidelines for the collection of clinical data and/or administration of clinical studies.
• Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and Monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.
• Evaluate and interpret collected clinical data in conjunction with principal investigator(s) as appropriate; prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions. Confer with principal investigator(s) to assist in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication.
• Coordinate the development of forms, questionnaires and the application of research techniques; assist in writing procedures manuals for data collection and coding. Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.

Regulatory:

• Assure compliance of general and study specific regulatory related processes and applicable regulations for the reporting of events to regulatory agencies. Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes. Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees, maintain annual approvals, amendments, and safety events, process data queries and ensure resolution, maintain essential staff documents (CV’s, licenses, site laboratory certifications) coordinate Human Protections Training for personnel.
• Perform regulatory audits on cooperative group, industry sponsored, and protocols at clinical and affiliate sites, and submit findings and recommendations in writing. Develop work plans to address findings.
• Work closely with sponsor and study personnel on relevant regulatory issues.
• Develop Policies and Procedures pertaining to regulatory processes.
• Lead regulatory educational events for regulatory personnel.

All:

• Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate.
• Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies. Assist in training new personnel.
• Perform other related duties incidental to the work described herein.

Candidate Requirements: