Clinical Research Coordinator - 246110

Summary :

Subject matter expert and leader of a clinical trial team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and company's SOPs.

Responsibilities

Role & Responsibilities :

• Serve as leader of a study team to execute clinical trials
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
• Create training strategies and mitigation plans
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and company's SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor / CRO data capture systems and resolving queries
• Ensure confidentiality of patient protected health information, sponsor confidential information and company confidential information is maintained by all team members
• Develop communication and escalation strategies within teams to that ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and company SOPs
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP / ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
• Create and execute recruitment strategies in conjunction with patient recruitment staff
• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
• Incorporate understanding of how decisions affect the bottom-line including links between operations and company's financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
• Develop Quality Control strategies for team member projects
• Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
• Promote respect for cultural diversity and conventions with all individuals.
• Understand the disease process or condition under study
• Other duties as assigned

Qualifications

Education / Experience :

Required Licenses / Certifications :

Required Skills :

Required Physical Abilities :

NOTE : The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and / or as requested by management.