Job title: Clinical Research Coordinator
Job description: JOB DESCRIPTION Job Overview Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), a
JOB DESCRIPTION Job Overview Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning. Essential Functions . Provide clinical research support to investigators to prepare for and execute assigned research studies, including: . Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data . Attend all relevant study meetings . Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research . Recruit and screen patients for clinical trials and maintain subject screening logs . Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits . Design and maintain source documentation based on protocol requirements . Schedule and execute study visits and perform study procedures . Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness . Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics . Monitor subject safety and report adverse reactions to appropriate medical personnel . Correspond with research subjects and troubleshoot study-related questions or issues . Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards . Assist with study data quality checking and query resolution. . Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring. . Record, report and interpret study findings appropriately to develop a study-specific database. . Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards. . Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records. . Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies. . Assist research site with coverage planning related to staffing and scheduling for research projects. Qualifications . Bachelor’s Degree Req Or . High School Diploma or equivalent Req . 3 years’ relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician or equivalent combination of education, training and experience Req . Working knowledge of clinical trials . Working knowledge of the principles of Good Clinical Practices (GCP) . In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules . Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing . Good skill in using MS Windows and Office applications such as Access, Outlook and Word . Excellent interpersonal skills . Ability to pay close attention to detail . Ability to establish and maintain effective working relationships with coworkers, managers and clients . Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies Job Location – Pune Only
Location: Noida, Uttar Pradesh
Job date: Fri, 10 Sep 2021 22:14:39 GMT
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