We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
At Worldwide Clinical Trials we are the #UncommonCRO, with #UncommonTalent in CRAs & Project Managers. We have amazing people — smart, experienced, and united by a desire to change the course of medical science.
The Lead Clinical Research Associate (LCRA), 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. A Lead CRA can expect to travel 25-30%.
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. The therapeutic area for this role is CNS, specifically ALS.
- 1st point of contact for CRA’s and In-house CRA’s, provide 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.
- Requires a bachelor degree or a two-year nursing degree
- A minimum of 8 years’ field monitoring experience required
- Must have previous experience as a Lead CRA (or equivalent) or Project Management role coordinating clinical operations activities
- Previous work experience in a neurodegenerative indication is required
- Willingness to travel required
- Valid current passport required