Sr. Cra I

Updated Yesterday Location Pune MH India Job ID 25102025 Description Sr CRA I - Mumbai Location Client based 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 Should have minimum 5yrs of monitoring exp Should have experience of therapeutic area like Oncology Hematology cardiology neuropsychiatry rare disease and immunology Looking for candidate from Mumbai location Candidate should have Pharma background Performs site qualification site initiation interim monitoring site management and close-out visits performed on-site or remotely ensuring regulatory ICH-GCP and or Good Pharmacoepidemiology Practice GPP and protocol compliance Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions immediately communicates escalates serious issues to the project team and develops action plans Maintains a working knowledge of ICH GCP Guidelines or other applicable guidance relevant regulations and company SOPs processes Verifies the process of obtaining informed consent has been adequately performed and documented for each subject patient as required appropriate Demonstrates diligence in protecting the confidentiality of each subject patient Assesses factors that might affect subject patienta s safety and clinical data integrity at an investigator physician site such as protocol deviation violations and pharmacovigilance issues Per the Clinical Monitoring Site Management Plan CMP SMP Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form CRF is accurate and complete via review of site source documents and medical records Applies query resolution techniques remotely and on site and provides guidance to site staff as necessary driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture Verifies site compliance with electronic data capture requirements May perform investigational product IP inventory reconciliation and reviews storage and security Verifies the IP has been dispensed and administered to subjects patients according to the protocol Verifies issues or risks associated with blinded or randomized information related to IP Applies knowledge of GCP local regulations and organizational procedures to ensure IP is appropriately re labelled imported and released returned Routinely reviews the Investigator Site File ISF for accuracy timeliness and completeness Reconciles contents of the ISF with the Trial Master File TMF Ensures the investigator physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations Documents activities via confirmation letters follow-up letters trip reports communication logs and other required project documents as per SOPs and Clinical Monitoring Plan Site Management Plan Supports subject patient recruitment retention and awareness strategies Enters data into tracking systems as required to track all observations ongoing status and assigned action items to resolution Understands project scope budgets and timelines for own and othersa activities in the clinical team manages site-level activities communication to ensure project objectives deliverables and timelines are met Must be able to quickly adapt to changing priorities to achieve goals targets May act as primary liaison with project site personnel or in collaboration with Central Monitoring Associate Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and or sponsor face to face meetings Participates and may with supervision lead global clinical monitoring project staff meetings inclusive of Sponsor representation as applicable and attends clinical training sessions according to the project specific requirements Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions May provide training or mentorship to more junior level CRAs May perform training and sign off visits for junior CRA staff as assigned May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead COL or operational line manager For Real World Late Phase RWLP the Sr CRA I will use the business card title of Sr Site Management Associate I Additional responsibilities include Site support throughout the study lifecycle from site identification through close out Knowledge of local requirements for real world late phase study designs Chart abstraction activities and data collection As required collaborate and build relationships with Sponsor and other affiliates medical science liaisons and local country staff Identify and communicate out of scope activities to Lead CRA Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns patient advocacy and Health Care Provider HCP associations Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings 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 Basic level of critical thinking skills expected 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 job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices This includes conducting on-site and remote monitoring developing tools procedures and processes to ensure quality monitoring 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 Individual contributor with developing subject matter expertise and responsibility for processes In-depth knowledge and skills within a professional discipline understanding the impact of work on related areas May be responsible for entire projects or processes within area of responsibility Share this job