Clinical Research Associate 2

Responsibilities

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
• Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.

Requirements

• Qualifications in a related science or health care discipline.
• Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 experiences in on-site monitoring and site management experience is mandatory.
• Experience with renal/nephrology and oncology studies.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in the following technical areas: ethical and participant safety considerations, site start‑up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem‑solving, decision making, and strategic thinking.
• Demonstrate solid interpersonal communication, presentation skills, and flexibility to work well within a multi‑disciplinary team both autonomously and with a wide range of varying stakeholders.
• Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
• Ability and willingness to travel.

Hard Skills

• clinical trial management
• on‑site monitoring
• site management
• ICH‑GCP guidelines
• risk management
• quality management
• scientific concepts
• clinical research design
• negotiation
• conflict resolution

Soft Skills

• interpersonal communication
• presentation skills
• critical thinking
• problem‑solving
• decision making
• strategic thinking
• flexibility
• adaptability
• motivation
• training