Research & Development Specialist

Responsibilities

• Facilitate assay development, conduct instrument validations and implement new testing to meet the needs of clinical trials protocols, clients and regulatory requirements.
• Develop validation plans, validation summary reports, stability study summary reports, correlation plans and correlation summary reports to meet regulatory requirements.
• Prepare Standard Operating Procedures for newly developed test procedures and relevant documentation, as necessary.
• Research and identify suppliers of laboratory consumables and equipment options for new tests to support clinical trials opportunities.
• Comply with policies for the safe, secure and confidential processing and storage of patient and other laboratory information.
• Perform the investigation and corrective action for assay troubleshooting and proficiency testing failures.
• Responsible for assay / panel pre-validation and validation and correlation testing globally.
• Ensure all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP) etc.
• Provide supporting information to Scientific Affairs in the evaluation of appropriate testing and/or methodology.
• Liaise with technical staff on feasibility of testing for new study requirements.
• Provide pricing as needed to Proposals team.
• Provide supportive information for consultation and technical support to clinical trials clients and operational staff.
• Responsible for communications (meetings, calls audits etc.) with clients and formulate responses as required.
• Assess the impact of manufacturer / vendor communications and complete associated documentation.
• Provide study management and direction of laboratory teams for the implementation of analytical method validations.
• Document and ownership of any quality documentation (Note to File, Quality Event, CAPA, deviation, change control) as appropriate within the required timeframes.
• Participation in all activities that seek to ensure compliance with GCP guidelines and accreditation schemes (e.g. CAP).
• Preparation of documentation for and participation in internal and external audits (client and regulatory).

Requirements

• BS in Life Sciences
• 3+ years in Laboratory experience

Preferred Qualifications

• NYS Medical Technologist License
• EP Evaluator experience