In collaboration with our client, the Clinical Site Ambassador (CSA) is responsible for the developing and maintaining the relationship with the site. The CSA is the main point of contact for the site and will be responsible for knowing all aspects of the site capabilities and structure; being an expert on their sites. In addition, the CSA will perform all site management and monitoring activities at a clinical site(s). The CSA will ensure clinical studies are performed in accordance with study protocol, standard operating procedures and associated plans, and relevant local and internal regulations, legislation and ICH/GCP guidelines.
- The CSA will serve as the single point of contact for the assigned sites for the lifecycle of the study in addition to developing and maintaining the relationship pre and post the study timelines. This includes, but not limited to feasibility, study-start-up, essential document/TMF maintenance etc., in addition to supporting the site and other internal client functional areas such as Safety/Pharmacovigilance, Regulatory, Clinical Trail Supply, etc.
- The CSA will be assigned clinical monitoring activities in a single country or in several countries ensuring appropriate clinical study conduct.
- The CSA will ensure subject safety and verify diligence in protecting the confidentiality of each subject.
- The CSA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
- The CSA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
- The CSA will have to anticipate, recognize and resolve issues for the assigned study sites.
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- Perform Investigator feasibility and capability assessments to support site evaluation: e.g. phone contacts, questionnaire in the appropriate country
- Serve as single point of contact with the site to collect and review site documents which will be used for both CA/EC submissions and Approval to ship IMP; ensure quality and accuracy of documents in accordance to ICH/GCP and local regulations, requirements and guidelines.
- Depending on the region, support and/or make initial and ongoing CA/EC submissions.
- Proactively support contract and budget negotiations and payment processes, as requested
- Review and/or input to study protocol, CRF and validation tools, as needed
- Participates in investigators meetings and assists in the preparation of these meetings, as assigned
- Conduct of site qualification visits (pre-study visits), site initiation visits, interim site visits and site close out visits, in accordance to SOPs, ICH/GCP
- Follow Protocol(s)/Amendment(s), Standard Operating Procedures (AC and CSL SOPs) Code of Federal Regulations (CFR) Good Clinical Practice (ICH GCP), and local regulation
- Coordinates between site and appropriate contacts to ensures the site is equipped with all necessary supplies to perform study procedure
- Ensures all project specific training is conducted and documented for the site throughout the life of the trial
- Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc.
- Trains on and adheres to the Monitoring Plan
- Support creation of materials as needed to successfully execute assigned responsibilities, as needed
- Coordinates between site and applicable parties to ensure sites have all applicable study required accesses
- Writes visit reports and corresponding site visit confirmation and follow-up correspondence for all site visit types
- Perform Lead CSA activities on a project as needed and assigned
- Attend team meetings as needed for the clinical trial
- Ensure data quality of assigned sites, by performing source document verification, source data review, review regulatory documents and investigational product, and prepare trip reports as outlined in the Monitoring Plan
- Responsible for regular communication to the site and follow-up and resolution of all site questions, issues, concerns, including but not limited to protocol questions, visit follow-up items, queries, action items, protocol deviations, etc.
- Ensures site visits are scheduled and conducted in accordance to the Clinical Monitoring Plan (schedule and activities).
- Maintains awareness of key study performance indicators for assigned sites including subject recruitment and retention strategies
- Responsible for regular communication and escalation to the study team (e.g., Lead CSA) regarding site status, issues, etc.
- Responsible for maintaining relationships with and serve as single point of contact for communications with all site staff including the Principal Investigator, sub-Investigations, Study Coordinators, Pharmacist(s), Laboratory Personnel, etc.
- Responsible for IP accountability and proper maintenance of IP processes and documentation at the site
- Perform co-monitoring visits and/or mentoring as assigned
- Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements, IP management, SAE reporting requirements
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles the ISF with the Trial Master File (TMF) to ensure audit readiness, including filing of all applicable documents
- Supports site audit and inspection activities as needed
- Participates in and completes all relevant job/study related trainings
- Performs activities in other clinical research areas according to the directive of superior
- The ideal candidate has a Bachelor's degree/Registered Nurse is preferred or approximately (5) years monitoring experience. Prefer scientific discipline and multiple therapeutic experiences
- A minimum of 4 years of monitoring experience or combination of on-site monitoring and clinical research experience or education; industry certification preferred.
- For countries other than US and Canada, a minimum of 2 years of experience conducting and supporting RA/CA and IRB/EC submissions and regulatory document start-up activities.
- The ability to perform travel up to an average of 80%, depending on project needs
- The candidate must have excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail
- The candidate must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum
- This role may be office and/or home-based/field-based however regular infrequent visits to a Company office will also be required.
- Applicable Standard Operating Procedures
- Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local regulations
- 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
- Good Clinical Data Management Practices
- HIPAA - Protected Health Information/GDPR-General Data Protection Regulation, as applicable
- Drug Development and Regulatory Approval Processes (depending on applicable territory(ies)
- Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.
- You must be fluent in the language of the territory you are assigned to as well as written and oral English (any additional languages would be appreciated).
- Candidates must be in possession of a current passport or identity card and a compliant and valid driving licence.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.
Equal Employment Opportunity
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 or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. 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 meet to discuss the appropriate alternatives available.