Clinical Research

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
• Ensure regulatory, ICH-GCP/GPP and protocol compliance
• Evaluate site and site staff performance, communicate serious issues, and develop action plans
• Verify informed consent, subject confidentiality, safety, clinical data integrity, protocol deviations and pharmacovigilance issues
• Assess site processes and conduct source document review and medical-record review
• Verify clinical data in case report forms and resolve queries remotely and on site
• Use hardware and software to support clinical study data review and capture
• Verify electronic data capture compliance
• Perform investigational product inventory, reconciliation, storage, dispensing and administration checks
• Review Investigator Site Files and reconcile them with the Trial Master File
• Document monitoring activities and enter observations and action items into tracking systems
• Support subject/patient recruitment, retention and awareness strategies
• Manage site-level activities and communication to meet project objectives, deliverables and timelines
• Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant
• Prepare for and attend investigator and sponsor meetings and clinical training sessions
• Provide guidance on audit readiness and support audit preparation and follow-up
• Mentor junior CRAs and perform training/sign-off visits as assigned
• Potentially perform clinical operations lead tasks under supervision

Clinical Research Associate

• Identify and assess new potential investigators and sites
• Recommend sites during feasibility and selection phases
• Conduct pre-study, initiation, monitoring, and close-out visits
• Monitor site performance, data quality, and protocol compliance
• Act as a key point of contact for site personnel, providing training and support
• Use data insights to assess risks and drive decisions
• Support regulatory audits, EC submissions, and system access coordination

Clinical Research Associate – DACH

• Organise, coordinate, and monitor clinical trials in accordance with ICH-GCP guidelines and internal SOPs
• Recruit, select, and train investigators and study sites
• Conduct study initiation visits, routine monitoring visits (on-site / remote), and close-out visits at study sites throughout Germany
• Communicate with study sites and maintain written documentation
• Identify on-site issues and escalate them to the study sponsor
• Prepare and submit documentation to ethics committees and competent authorities
• Support correspondence activities
• Monitor schedules and deadlines
• Maintain study data in databases (Microsoft Access, Microsoft Excel)
• Support regulatory submission activities and maintain the Trial Master File (TMF)

Clinical Monitor, Clinical Research Associate, CRA

• Serve as a trusted first point of contact for patients and provide professional support
• Coordinate and schedule patient appointments
• Ensure optimal appointment planning
• Maintain and manage patient data carefully and in compliance with data protection regulations
• Maintain and update patient lists
• Ensure structured data management
• Prepare expense compensation payments
• Support additional administrative tasks

Reception Specialist

• Support the organization and conduct of clinical trials at investigative sites
• Manage relationships with investigators and obtain and document study status updates
• Prepare, conduct, and follow up on site initiation, monitoring, and close-out visits—on-site or remotely—including report preparation
• Conduct feasibility assessments for new projects
• Validate study data as part of source data verification
• Verify that investigative sites comply with applicable guidelines and legal requirements
• Support audits and inspections at investigative sites
• Raise study data queries, coordinate them with relevant contacts, and monitor the query process
• Work closely with Data Management and Project Management
• Train investigators and study coordinators on the use of EDC software
• Serve as the liaison between investigative sites, Project Management, and other involved teams
• Prepare study documents, including shipment and tracking, or support these activities
• Prepare documentation for submissions to regulatory authorities and ethics committees
• Independently manage the Southern Germany region
• Visit investigative sites on a regular basis; travel approximately 30–40%

Clinical Research Associate, Clinical Monitor, Site Manager

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate study setup and monitoring activities
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations
• Build the company’s network of experienced clinical research professionals for future project requirements

Senior Clinical Research Associate

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations, and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support clinical study teams with larger-scope trials
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations