Monitoring Oversight Lead (Lead CRA)

Responsibilities

• Lead CRA I-IV teams on study and/or operational line management level.
• Manage assigned departmental project tasks/systems in principle areas of responsibilities identified below.

Study Specific Lead CRA Duties

• Take on a pivotal role in providing strategic direction and oversight for assigned clinical studies.
• Work closely with cross-functional teams, including Project Management, Data Management, and Medical Writing.
• Lead the planning, execution, and management of complex clinical trials.
• Lead a group of CRAs in a study, operational follow up of entire site management activity in a study included but not limited to data entry, query resolution, eligibility reviews, compliance and timely management of the study specific deadlines.
• Manage site visit needs and planning, site visits report review and approvals, training other CRAs and new team members, risk assessment, and ensuring adherence to regulatory requirements and industry standards.
• Manage the 3rd party vendors such as CROs providing monitoring service and Flying Study Nurses or Site Coordinators.
• Foster strong relationships with investigational sites, regulatory bodies, vendors, and internal cross-functional teams to ensure effective communication, study alignment, and timely resolution of issues.

Line Manager Lead CRA Duties

• Assume leadership responsibilities for overseeing and managing a team of Clinical Research Associates (CRAs).
• Provide recruiting, mentorship, coaching, guidance, onboarding and support to junior CRAs, as well as overseeing their day-to-day activities performance and professional development while fostering a culture of collaboration, excellence, and continuous learning.
• Collaborate with senior management to develop and implement strategies to optimize team performance, ensure adherence to company policies and procedures, and drive continuous improvement initiatives within the Clinical Affairs department.
• Ensure timely submission of expense reports, accurate time reporting, on time vacation planning, timely planning of site travel according to Travel Policy, timely acknowledgment of Standard Operating Procedures (SOPs) and completion of required training, timely completion of the compliance tools provided by the management (such as CRA scorecards.. etc.).
• Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Healthcare standards, guidelines, and policies.
• Communicate effectively to address queries, provide updates, and facilitate resolution of issues.
• Be the primary point of contact between the sponsor, investigational sites, and other stakeholders involved in the clinical trial.
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study.
• Follow-up with site to gauge progress on any action items and assess needs to reinforce completion of those action items.
• Create corrective and preventive action plans and trend reports.
• Identify potential sites for research participation and perform study start-up activities.
• Train sites on proper data collection and reporting of safety-related events.
• Conduct study initiation visits (SIVs).
• Provide input into final study site selection.
• Aid in initial and ongoing site personnel training as required.
• Manage site activities during study maintenance.
• Oversee the overview of the safety of the patients with PI (SAE/AE Reports, etc.), conduct safety/efficacy review of clinical data, full ownership of investigator sites for assigned studies with responsibility for the successful management of the site, participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices.
• Develop effective relationships with investigator site staff to ensure that key clinical metrics are met.
• Identify site needs, provide solutions to facilitate the clinical trial process.
• Be involved in site management activities.
• Close down research activities at the conclusion of the study.

Qualifications

• In depth experience in clinical research monitoring, typically gained over 8 or more years.
• Ability to work independently without supervision of daily CRA activities.
• Knowledgeable of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects.