Main Responsibilities
The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site.
Feasibility Activities
- Involvement in the site selection process together with the Registries Team.
Study Start-up Activities
- Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
- Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
- Prepare EC cover letter and any additional materials required (if applicable)
- Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
- Prepare the Insurance Certificate application when applicable.
- Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
- Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
- Assist with the upload & file of Study Start-up documentation into the eTMF.
- Ensure that all parties are informed about project progress, changes, and any issues that arise.
Site Monitoring
- Off-Site Visits
- Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
- Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits – Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
- Onsite (where local hub affiliates are located)
- Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
- Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits – Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
- Management of the Site Data:
- Reviews study data from various sources remotely.
- Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects.
Site Management
- Recruitment Follow up on patient enrolment and patient status.
- Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems.
- Develops collaborative relationships with investigational sites and other stakeholders as applicable.
- Liaise with Vendor for different activities (startup, onsite monitoring).
Safety & Quality
- Assure adequate safety reporting process of the site, and that site is submitting and/or
notifying safety information to EC/IRB/RA according to country regulations, site SOP.
- Quality control of study conduction at site level – with “Audit/inspection readiness” mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.
Study Administration
- To maintain all the tables, trackers and databases updated to follow the study progress
locally and globally.
- To know and use all the tools needed.
- Participates in the investigator payment process, if applicable
- To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required.
- Study Meetings: To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.
- People: (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business
- Performance: (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA’s reports, including monitoring visit reports, progress reports,
- Process:(1) Involvement in the site selection process together with the Clinical Project Lead (CPL), Registries Regional Leads and Local Medical Affairs. (2) Assist in the collection of site documents, Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee. Prepare EC cover letter and any additional materials if required. Ensure appropriate follow-up with EC for additional questions and to inform sites (if applicable). Prepare the Insurance Certificate application when applicable. Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites. Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site, if applicable Assist with the upload & file of Study Start-up documentation into the eTMF. (3) Plan, prepare, conduct, report and follow up site (and satellite sites) visits-Site Selection, Site. Initiation, Routine Monitoring (Remote /) and Close Out Visits according to Study. Manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. (4) Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects. (5) Assure adequate safety reporting process of the site, and that site is submitting and/or notifying safety information to EC/IRB/RA according to country regulations, site SOP. Quality control of study conduction at site level – with “Audit/inspection readiness” mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. (6) To maintain all the tables, trackers and databases updated to follow the study progress locally and globally. To know and use all the tools needed. To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required. To participate with the rest of the registries team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.
- Stakeholder: (1) CRAs identify all relevant stakeholders, including sponsors, investigators, regulatory bodies, and patients. Understanding each stakeholder’s role and influence is essential. (2) Communication: Effective communication is vital. CRAs ensure that stakeholders are kept informed about the study’s progress, any issues that arise, and the outcomes. This involves regular updates, meetings, and reports. (3) Building Relationships: Establishing and maintaining positive relationships with stakeholders is crucial. This involves understanding their needs, expectations, and concerns, and addressing them promptly. (4) Conflict Resolution: CRAs often mediate conflicts between stakeholders. They must be adept at negotiating and finding solutions that satisfy all parties involved. (5) Compliance and Ethics: Ensuring that all stakeholders adhere to regulatory and ethical guidelines is a key responsibility. CRAs monitor compliance and address any deviations promptly. (6) Feedback and Improvement: Gathering feedback from stakeholders and using it to improve processes and outcomes is an ongoing task. This helps in building trust and improving future collaborations.
- Experience:
- 3+ years of experience in Clinical research & development including clinical trial monitoring experiences. Rare diseases or observational studies, real world evidence experience will be a plus.
- Attention to Detail: Critical for monitoring trial data and ensuring accuracy.
- Problem-Solving: Ability to address and resolve issues that arise during trials.
- Project Management: Skills in managing timelines, budgets, and resources.
- Technical Writing: Proficiency in writing reports, protocols, and regulatory documents.
- Experience in working in global projects and international matrix environment.
- Soft skills:
- Communication: Excellent written and oral communication skills to interact with various stakeholders.
- Adaptability: Ability to adapt to changing requirements and environments3.
- Interpersonal Skills: Building and maintaining positive relationships with stakeholders3.
- Time Management: Efficiently managing time and prioritizing tasks.
- Ethical Judgment: Strong sense of ethics and integrity in conducting clinical research.
Technical skills: Good Clinical Practice (GCP): Understanding and adherence to GCP guidelines.Regulatory Requirements: Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).Clinical Trial Processes: Familiarity with clinical trial phases, protocols, and methodologies.Data Management: Skills in data collection, analysis, and reporting.
- Medical Terminology: Proficiency in medical terminology and procedures.
- Competent with Microsoft Office products.
- Education: Degree in a Pharma/scientific discipline or a related Life science degree
- Languages: High Proficiency in written and spoken English.