Clinical Research Associate Ii

Updated Yesterday Location Pune MH India Job ID 25102438 Description Clinical Research Associate II Client base mumbai location 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 youa 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 a 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 a wea re able to create a place where everyone feels like they belong Job Responsibilities Bachelor s degree required preferably within Life Sciences or equivalent 3 years of relevant clinical research experience with at least one year previous monitoring experience is required able to work independently 3 years of monitoring experience preferred Must Have a Has basic to good knowledge of ICH GCP Guidelines and applicable local laws and regulations Health Authorities which govern clinical trials a Experience in the drug discovery development process a Knowledge and understanding of clinical research processes regulations and methodology a Understands clinical landscape with practical knowledge of a variety of medical settings and medical records managementa a Organization and time management skills a Ability to build maintain and strengthen relationships even under pressure and or in difficult situations Preferred a Relevant prior Pharma Biotech Sponsor employment or experience as a clinical study coordinator At least one year previous monitoring experience is required 3 years preferred General Description a Responsible for the oversight of the progress of a clinical trial and of ensuring that it is conducted recorded and reported in accordance with the protocol Standard Operating Procedures SOPs Good Clinical Practice GCP and the applicable regulatory requirement s a Act as one of the points of contact at a Site level for internal and external stakeholders Key Responsibilities and Duties a Identifies new potential Investigators through ongoing collaborations with internal and external stakeholders a Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials a Develop Site relationships incl Contract Research Organization related issue management and non- registrational Investigator Sponsored Research Studies a Recommends sites during the site feasibility and or site selection process a Conducts pre-study visit as appropriate a Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation a Reviews site activities and quality through on-site and off-site visits Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan procedural documents protocol ICH GCP Guidelines and other local regulations as applicable a Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor a While monitoring demonstrates the ability to use data to assess risks identify issues and make appropriate decisions a Serve as a point of contact for Sites a Provides trainings to sites a Performs site closure activities when all required protocol visits and follow-up are completed a Manages multiple protocols across multiple therapeutic areas which may require travel based upon assigned site location and or geographic territory a Ensures completeness and quality of data submitted from study sites Ensures eCRF data is available and current by using the available systems to follow site activities a Oversees activities of site personnel over whom there is no direct authority a Motivates influences the site to meet study objectives including enrolment and retention goals Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method a Anticipates identifies and proactively supports site in resolving issues as they occur Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team Initiates recommends documents and communicates corrective actions as needed and follows up to ensure corrective preventive actions based on root cause analysis are implemented a Involvement in Regulatory Compliance audit inspection process as needed This includes the development and implementation of site corrective and preventive actions a Prepares and submits written reports both monitoring and administrative in a timely accurate concise professional and objective manner a May support Ethics Committee submission ICF review collection of documents to from site a May support ensuring access to eDC and client vendor systems is available for clinical trial site personnel a May support equipment calibration and tracking a May support preparation of Study Initiation Visit materials a May support coordination and ensure database lock timelines are met as required locally Qualifications Bachelora s degree or RN in a related field or equivalent combination of education training and experience 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 Ability to manage required travel of up to 75 on a regular basis 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 youa 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 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 Summary Roles within Clinical Monitoring CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends ensuring that trials are conducted in accordance with established clinical practices Collaborates with site teams to develop and implement tools procedures and processes that enhance quality monitoring and support the overall success of clinical trials Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty but may manage two or fewer employees May direct the work of lower level professionals or manage processes and programs The majority of time is spent contributing to the design implementation or delivery of processes programs and policies using knowledge and skills typically acquired through advanced education Established and productive individual contributor May manage defined components of projects or processes within area of responsibility Requires practical knowledge of a professional area typically obtained through education combined with experience Share this job