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Overview:
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.
A Senior Clinical Research Associate (SCRA) is responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s). The Senior CRA may be responsible for multiple projects and must be able to work both independently and in a team environment. The Senior CRA may also be responsible for mentoring CRAs and other Clinical Operations (CO) staff.
- The SCRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct.
The SCRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
- The SCRA 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 SCRA will have to anticipate, recognize and resolve issues in the served study sites and may oversee such activities of CRA/other CO staff
**Responsibilities**:
- Follow Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs) Code of Federal Regulations (CFR) Good Clinical Practice (ICH GCP), and local regulations
- Travel to research sites as needed
- Complete project-specific training and attend client meetings as needed for the clinical trial
- Act as the Lead CRA on a project as needed
- Create materials as needed to successfully execute assigned responsibilities
- Perform source document verification, source data review, review regulatory documents and investigational product, and prepare trip reports as outlined in the Monitoring Plan
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
- Review and/or input to study protocol, CRF and validation tools
- Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc.
- Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities
- Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
- Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country
- Conduct of site qualification visits (pre-study visits)
- Conduct of site initiation
- and site close out visits
- Conduct of regular monitoring visits
- Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
- Writes a corresponding site visit follow-up letter for the purpose of on-site quality optimization
- Distributes any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.)
- Responsible for the quality of data from his/her own sites
- Resolves questions/issues with investigator/trial staff including query verification
- Resolves and writes Data Clarification Forms, and reviews data-listings
- Manages his/her own visit schedule, appointments and the following-up of issues between visits under, along with regular communication with the sites and the clinical study team
- Maintain close contact with the investigators on-site, the centre study coordinator the ph
