Description FSP Senior Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do.We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture - where you can authentically be yourself.Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with.Why?Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Job responsibilities The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local country team, working in close collaboration with other CRAs and the Country Operations Management (COM) Team to ensure that study commitments are achieved in a timely and efficient manner.The Sr.CRA acts as the main contact with the study site and is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.A Sr. CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg.Lead CRA, etc).Responsibilities • Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).• Driving performance at the sites.Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.• Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.• Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones.Document recruitment barriers and mitigation plans.• Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)• Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with SOPs.• Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, SOPs and local requirements.Supporting/participating in regular QC checks of the eTMF.• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance.Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.• Collaborating with local Medical Affairs and other internal stakeholders, as needed.• Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO and/or Quality Group as required.• Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with SML and Quality Group.#LI-NC1 Qualifications What we're looking for Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Solid UK monitoring experience at a Senior CRA level gained from Pharma or CRO environment.Lead experience would be a bonus.Excellent knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies.Excellent communication, presentation and interpersonal skills.Moderate level of critical thinking skills expected.Ability to manage required travel of up to 50% on a regular basis Previous rare disease experience gained as a CRA.Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.Learn more about Syneos Health .Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive.The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.Further, nothing contained herein should be construed to create an employment contract.Occasionally, required skills/experiences for jobs are expressed in brief terms.Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.#LI-NC1
