Clinical Trial Lead-Homebased, Nationwide
A Clinical Trial Lead (CTL) is a member of the project team responsible for the execution of the clinical trial(s) at the site level, accountable for development and execution of the clinical monitoring plan (CMP), site identification and selection, CRA and site training, development of CRA and site materials, trackers, and logs necessary to track and document deliverables. The lead CRA will review monitoring visit reports and track actual to projected variables and parameters related to CRA & site activities. All activities will be in compliance with cGCPs, country specific regulations, ICH Guidelines, and SOPs.
- Site Identification, Recruitment & Qualification
- Participate in the qualification of sites, Site Activation, Site maintenance, Site closure
- Develop study specific templates
- Develops study specific plan for release of IP
- Participates in documents requiring translation and the process for their translation
- Develop ICF template
- Oversee projection of planned site activation and SIVs
- Develop contents of investigator site file, site operations manual and pharmacy manual
- Reviews visit reports and F/U letter
- Review and prepare weekly status reports
- Establish study milestones and ensures accurate tracking and reporting of study metrics.
- Provide input and manage clinical trial budgets and staffing/resourcing plans.
- Ensure that clinical trials are conducted in accordance with country's regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
- May provide study-specific direction, training and mentoring to CRAs, and support staff as appropriate, and may provide guidance to other team members.
- Participate in clinical operations initiatives and programs as assigned.
- Client faced in day to day operations
- Participates in bid-defense meetings, kick off meetings, and investigator meetings.
- Travel to sites and meetings as needed
- Other duties as assigned and may change with change in studies/Advanced Clinical needs
Education: Bachelor's degree, in biological sciences, healthcare, or pharmacy medicine preferred
Experience: 5+ years related experience. CRA level experience (both CRO and industry experience are acceptable). Prefer scientific discipline and multiple therapeutic experiences. The candidate must have:
- Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
- Strong computer proficiency in MS Office including Word, Excel, and PowerPoint.
- Strong critical thinking, problem solving and analytical skill sets.
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- Excellent organizational and record-keeping skills.
- Ability to maintain excellent working relationships with a broad range of trial staff.
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.
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Meet Some of Advanced Clinical's Employees
As a medical writer, Shaniya is responsible for compiling the data from clinical study reports, analyzing what’s been learned from conducting the trial, and summarizing that information into a scientific document.
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