We are currently searching for a skilled professional to join a well-known client’s team as a remote Lead Clinical Site Ambassador. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

A Lead Clinical Site Ambassador (LCSA) is responsible for the overall Site Management activities of the assigned CSAs and therefore the overall study site relationship status for the region(s) assigned. The LCSA is a member of the Study Execution Team (SET) responsible for the execution of the clinical trial(s) at the site level, accountable for development and execution of the Monitoring Plan (MP), support site identification and selection, CSA and site training, development of materials, trackers, and logs utilized by the CSA(s) and sites necessary to track and document deliverables. The LCSA will review monitoring visit reports and track actual to projected variables and parameters related to CSA & site activities. All activities will be in compliance with cGCPs, country specific regulations, ICH Guidelines, and SOPs.

RESPONSIBILITIES
• Develop comprehensive Monitoring Plans (MP) inclusive of but not limited to:
• Monitoring standards (During start-up, enrollment, maintenance & study close)
• Communication flow
• Training of CSAs
• Monitoring strategy and methods (e.g., remote, on-site, etc.)
• Site training
• Investigator Site File oversight
• Investigational product management
• Source data verification processes
• Protocol deviation reporting
• Actively participates in the study startup process including site identification, qualification, selection and initiation activities
• Coordinate Study-Start up activities of the CSAs and collaborating with Global Study-Start-Up per study timelines
• Lead Clinical CSA activities through site selection, activation, maintenance and study closure
• Develop study specific templates for use by the Clinical Site Ambassador team (CSAs) and/or sites
• Establish clinical monitoring study milestones and ensure accurate tracking and reporting of study metrics
• Provide study-specific guidance, training, and support for the CSA Team
• Prepare status reports and agendas, as required
• Effectively interact and communicate with the SET and other functional areas, as required
• In larger programs, supports the Lead CSA who is a member of the SET
• Lead internal and external vendor meetings, as assigned
• Ensure that clinical trials are conducted in accordance with country’s regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures
• Conduct CSA activities at assigned sites, including co-monitoring visits as needed
• Review monitoring visit reports and track report metrics to ensure compliance
• Prepare and attend kick off meetings, investigator meetings and other study specific meetings as required
• Assist with resolution of CAPAs, as needed
• Mentor Lead CSAs and CSAs as assigned
• Other duties as assigned

EXPERIENCE
• A minimum of four (4) years of clinical trial lead/management experience approximately. Prefer scientific discipline and multiple therapeutic experiences.
• An additional 2 years of on-site monitoring and clinical research experience or education; industry certification preferred.
• Experience with management of complex protocols (i.e., oncology, etc.) is preferable.

EDUCATION
• A degree (BSc/MSc) or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist)
• Certification Member of ACRP/ICR/SoCSA preferred

QUALIFICATIONS
• Excellent verbal and written communication, and presentation skills
• Excellent interpersonal and organizational skills with attention to detail
• Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint
• Strong critical thinking, problem solving and analytical skills
• Ability to efficiently organize and prioritize tasks within a multifaceted framework and set deadlines
• Excellent documentation skills
• Ability to maintain excellent working relationships with a broad range of trial staff
• Ability to work well in a team environment but also independently without significant oversight
• Flexibility in work hours and ability to travel
• Must be fluent in English and in the languages of the regions/territories that are assigned
• Must possess a current passport, identity card, and valid driver’s license

To be a best-fit your strengths must include:
• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.