The Lead Clinical Research Associate (LCRA) - NASH will work closely with Project Management and a CRA team to lead the delivery of site management clinical operations activities through the coordination of a team of Clinical staff globally or within a geographic region. This position is home-based and may be located anywhere within the continental United States.

The LCRA is responsible for ensuring site qualification, initiation, interim monitoring, site management, and study close-out activities for studies in accordance with the study protocol and study plan. The successful candidate will ensure the overall quality and timeliness of clinical deliverables for assigned programs and/or region.
 
 
RESPONSIBILITIES:

• 1 st point of contact for CRA's and In-house CRA's , p rovide leadership and direction to clinical site management team members from study start through to closure
• Point of escalation for clinical site management and investigator sites
• Drafting (and finalizing) the Clinical Monitoring Plan (CMP) and customization of WCT monitoring visit report/letter templates, site/monitoring tools
• May assist in the design and development of additional study-related documents including (but not limited to) Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plan, etc.
• Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and Sponsor as needed
• Ensures the CRA team is staffed to meet the monitoring demands of the project or program in compliance with the approved budget and CMP
• Supports Project Management in the development of an implementation of a recruitment strategy in countries and sites assigned
• Along with the Project Manager, LCRA will lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target
• Works with Project Management to take responsibility for the quality of the site data and addressing any identified needs with action plans with measurable metrics to ensure data cleaning is completed as specified
• Supports Project Management in the review of data trends and trip report issues identified for re-training of sites or CRA team. Escalate issues and trends per study expectations
• Formulates regional monitoring strategy and accountable for Forecasting of site visits w/CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed
• Review/finalize trip reports according to SOPs, expectations and as outlined in the annotated report
• Ensures all project follow up letters are prepared and follow up actions from MV (any site visits) are closed
• May perform site qualification, initiation, interim monitoring, and/or closeout site visits as needed
• If budgeted, conduct co-visits for the specific study. The focus of the visit is to ensure the quality of the site, of the CRA work and of the study procedures.

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 
OTHER SKILLS AND ABILITIES:

• Ability to negotiate and influence with diplomacy in order to achieve results
• Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified
• Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision
• Ability to lead and motivate a team across locations and cultures
• Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
• Strong customer focus, ability to interact professionally within a sponsor contacts
• Extensive understanding of clinical research principles and process
• Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
• Thorough understanding of standard operating procedures
• Proficiency with IxRS, CTMS and EDC systems

 
REQUIREMENTS:

• A minimum four-year college curriculum with a major concentration in biological, physical or health studies and a minimum experience of eight years as a Clinical Research Associate, OR
• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of 10 years as a Clinical Research Associate
• Must have previous experience as a Lead CRA (or equivalent) or Project Management role coordinating clinical operations activities
• Willingness to travel required
• Valid current passport required

 
Worldwide Clinical Trials is an Equal Opportunity Employer

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