16 Protocol Compliance Jobs

As a Senior Clinical Operations Specialist (Senior CTA) at Syneos Health in Athens, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include: - Assisting Clinical Monitoring staff with site management activities, acting as a Sponsor representative for assigned sites, and ensuring compliance with protocol requirements and study procedures. - Creating and maintaining project files, handling project correspondence, and participating in file audits. - Preparing and updating site manuals, reference tools, and other documents. - Inputting clinical tracking informatio...

As a Sr CRA I at Syneos Health in Beijing, you will play a crucial role in monitoring clinical research studies to ensure trials are conducted in accordance with widely accepted clinical practices. Your responsibilities will include conducting on-site and remote monitoring, developing tools and procedures for quality monitoring, and ensuring regulatory, ICH-GCP, and protocol compliance at all stages of the clinical trial process. Key Responsibilities: - Ensure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visits - Evaluate overall site performance, provide recommendations for site-specific actions, ...

In this role of CRA II/ Sr CRA I at Syneos Health based in Mumbai with a focus on Oncology, you will play a crucial part in overseeing and ensuring the integrity of clinical research studies by monitoring data and processes. Your responsibilities will include conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits. Additionally, you will be responsible for ensuring regulatory, ICH-GCP, and protocol compliance, as well as evaluating site performance and providing recommendations. You will also be involved in tasks such as assessing subject/patient safety, conducting source document review, and ensuring site compliance with electroni...

We are seeking a Clinical Business Analyst to support the enhancement and expansion of Clinical Data Review (CDR) dashboards . This role requires strong collaboration with client stakeholders, development teams, and analytics experts to drive the design and implementation of advanced dashboards for medical monitoring, protocol compliance, trial safety analytics, and regulatory reporting . The successful candidate will lead requirement gathering, user story creation, testing, and implementation support , ensuring alignment with clinical operations, biometrics, and regulatory expectations . Key Responsibilities: Client Collaboration Engage with client stakeholders (data managers, medical monit...

As a Clin Ops Specialist/CTA based in Athens, your role at Syneos Health will involve performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. You will assist Clinical Monitoring staff with site management activities, serving as a Sponsor representative for assigned studies and ensuring compliance with protocol requirements and relevant guidelines by communicating with sites. Additionally, you will create and assist with maintenance of Trial Master File (TMF) and project files, participate in file audits, prepare site manuals and other documents, update clinical tracking information databases, and tr...

As a Sr CRA I based in Beijing at Syneos Health, you will play a crucial role in monitoring clinical research studies to ensure they are conducted in line with established clinical practices. You will be responsible for both on-site and remote monitoring, developing tools, procedures, and processes to maintain quality monitoring standards. Your dedication to contributing to the design, implementation, and delivery of processes and programs will be instrumental in the success of clinical research studies. Syneos Health is committed to fostering a supportive and engaging work environment where career development, progression, and peer recognition are prioritized. As part of our Total Self cult...

As a Clinical Research Associate II (Sponsor dedicated) in Athens Homebase at Syneos Health, you will play a crucial role in ensuring site compliance with regulatory guidelines and protocol requirements. Your responsibilities will include performing site qualification, initiation, monitoring, management activities, and close-out visits either on-site or remotely. You will assess site performance, provide recommendations, and escalate any serious issues to the project team promptly. Your attention to detail will be essential as you verify the informed consent process, assess factors affecting subject safety, and review clinical data for accuracy and completeness. You will conduct source docum...

Detailed Job Role Coordinate clinical trials, ensure adherence to protocols and regulatory compliance, monitor data collection and patient safety. KRA (Key Responsibility Areas) Trial site monitoring, protocol compliance, data accuracy, safety monitoring KPI (Key Performance Indicators) Monitoring visits, protocol deviations, data quality, report timeliness Job Summary: We are seeking a detail-oriented Clinical Research Associate (CRA) to coordinate and oversee clinical trials, ensuring strict adherence to protocols, regulatory guidelines, and patient safety standards. The ideal candidate will have hands-on experience in monitoring trial sites and ensuring high-quality data collection. Key R...

Detailed Job Role Coordinate clinical trials, ensure adherence to protocols and regulatory compliance, monitor data collection and patient safety. KRA (Key Responsibility Areas) Trial site monitoring, protocol compliance, data accuracy, safety monitoring KPI (Key Performance Indicators) Monitoring visits, protocol deviations, data quality, report timeliness Job Summary: We are seeking a detail-oriented Clinical Research Associate (CRA) to coordinate and oversee clinical trials, ensuring strict adherence to protocols, regulatory guidelines, and patient safety standards. The ideal candidate will have hands-on experience in monitoring trial sites and ensuring high-quality data collection. Key R...

As a Clinical Ops Specialist at Syneos Health in Beijing/Shanghai, you will play a crucial role in ensuring activities are carried out in alignment with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include supporting Clinical Monitoring staff in site management activities, acting as a Sponsor representative for assigned studies, and maintaining communication with sites to ensure adherence to protocol requirements and study procedures. You will be responsible for creating and managing Trial Master Files (TMF) and project files, participating in file audits, preparing site manuals and reference tools, and updating ...

As a Senior Clinical Operations Specialist (Senior CTA) in the Hybrid model in Athens at Syneos Health, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include assisting Clinical Monitoring staff with site management activities, maintaining project files, handling project correspondence, participating in file audits, and preparing and maintaining site manuals and reference tools. Additionally, you will be responsible for updating clinical tracking information into databases, tracking documents, managing the shared mailbox, and coordinating site supplies and ma...

The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training, and close-out. You will be managing the execution of clinical trial projects from initiation to closeout across multiple projects, sites, and teams. Additionally, you will be responsible for managing site relationships to ensure compliance with regulations, budgets, and timelines. Providing operational insights for compliance with Protocol, SOPs, policies, and practices will be a key aspect of your role. Collaboration with project teams and sponsors is also expected. Your responsibilities will include site qualification, contract negotia...

As an experienced Verification Engineer with a minimum of 5 years of experience, your primary responsibility will be to lead the verification of DDR memory controller and PHY designs in compliance with DDR standards like DDR3, DDR4, DDR5, and other memory interface protocols. You will be required to develop and implement scalable, reusable, and efficient verification environments and testbenches for DDR designs using SystemVerilog, UVM, and other industry-standard methodologies. Ensuring protocol compliance is crucial, which includes validating command, data, and clock synchronization, read/write cycles, burst transfers, refresh cycles, error handling, and power management. Your role will in...

As a Clinical Research Associate (CRA), you will play a key role in conducting Phase I-IV clinical BA/BE studies. Your primary responsibilities will involve monitoring and managing activities at clinical sites to ensure that project timelines and deliverables are achieved. Building strong relationships with clinical sites and investigators will be essential, along with assessing protocol and regulatory compliance based on local and federal requirements, ICH GCP guidelines, and PSI SOPs. Your focus will be on safeguarding subjects" rights, safety, and well-being, as well as maintaining data quality. Your tasks will include preparing, conducting, and reporting on various activities such as sit...

Understands the OT routine, equipment and patients. Checks the surgery schedule and prepares for the cases: medication, consumables, instruments and equipment are available for the surgery Identifies instruments as per the surgery, checks cleanliness and proper functioning of instruments, pack and send for autoclaving / gas sterilization. Is aware of and implements all protocols hand washing, infection control, medication, narcotic policy, personal valuables, follows the dress code in and out of the restricted areas. Receives the patient in the preoperative area, checks for: right patient, correct documents, right surgery and transfers to the Operation Theatre. Procures all blood and blood p...

Develop and execute test plans for telecom systems. Perform functional, regression, and performance testing. Identify and document defects and issues. Collaborate with development teams to resolve problems. Ensure compliance with industry standards and protocols. Maintain testing documentation and reports.