- Experience Level
SUMMARY: The LCRA will work closely with PM and a CRA team to lead the delivery of site management clinical operations activities through the co-ordination of a team of Clinical staff globally or within a geographic region. Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan. Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region.
Tasks may include but are not limited to:
- Actively participate in the implementation and execution of clinical trial activities from study planning through closure.
- Provide leadership and direction to clinical site management team members from study start through 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
- Ensure compliance with clinical monitoring plan
- 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.
- Track and reports to PM on compliance, trends and study metrics.
- Supports the PM in ensuring CRA team is staffed to meet the monitoring demands of the project or program in compliance with approved budget and CMP
- Supports the PM in the development of and implementation of recruitment strategy in countries and sites assigned. Leads the tracking of recruitment and revision of site specific recruitment plans as needed to ensure enrollment stays on target.
- Supports the PM in taking 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 the PM 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 WCT SOPs, expectations and as outlined in the annotated report
- Follows up with CRAs regarding visits schedules, outstanding trip reports and follow up letters
- Tracking status of reports & action items
- 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 close out site visits as needed
- 1st point of contact for CRA’s and ihCRA’s
- Provides a key role in problem solving and 1st in issue escalation regarding monitoring and site issues, with proposed solutions to Project Management team and Sponsor as needed
- Supports the PM in the implementation of corrective actions for CRA team
- Assess and analyzes study and CRA metrics
- Proactively identifies and mitigates risk
- Reports to the PM/GPL of a study within matrix management structure
- Represents clinical site management on sponsor and other relevant study team calls
- May represent the Company as primary contact on projects
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expenses))
- If budgeted conduct co-visits for specific study. The focus of the visit is to ensure quality of site, of the CRA work and of the study procedures.
- Other tasks requested by PM not described in the above that are delegated to LCRA. The LCRA must consider whether the tasks fall into one of the above points. If not, it should be discussed with line manager (COM ) prior to agreeing to the task.
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:
- Excellent interpersonal, oral and written communication skills
- Excellent planning and organizational skills with effective time management
- Excellent presentation skills
- Flexibility to change
- Ability to manage multiple and varied tasks with enthusiasm
- 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
- Experience in the study therapeutic indication/area
- Thorough understanding of standard operating procedures
- Proficiency in Microsoft Office
- Proficiency with IxRS, CTMS and EDC systems
- 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 had experience as a Lead CRA (or equivalent) or Project Management role coordinating clinical operations activities
- Willingness to travel required
- Valid current passport required
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.