Join us on our exciting journey! IQVIA\u2122 is The Human Data Science Company\u2122, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Description PURPOSE Perform a variety of clinical procedures to collect, record,report and interpret data on volunteers enrolled and\/or seeking enrollment inclinical studies according to standard operating procedures (SOPs). Monitorvolunteer response to evaluate effect of investigational drug. Assist withdaily workload planning. RESPONSIBILITIES In Incumbents\u00a0in this job classification may workin the clinic, screening, recruitment, laboratories or any other departmentinto which they have cross trained, and may be expected to perform duties notspecified below. They may also specialize in particular aspects of this jobsuch as training, staffing or study coordination, and may not be required tocarry out all responsibilities indicated below. Collaborate with the Study Director\/Coordinatorto prepare for and execute assigned studies. Assist in ensuring that studyobjectives are met on time, within budget and according to applicable regulationsand quality standards. Captain\/lead studies, including: oReview of study protocols, case report forms(CRF), other study documents, and electronic data capture systems; oFeedback on clinical strategy and concerns; oClinical set-up and preparation of the studyincluding labeling specimen collection tubes and containers, setting up equipmentand documents; oPlan logistical activity for procedures as perprotocol; oGenerate materials, documents, and records; oAttend or delegating all relevant study meetingsincluding those with clients; oTroubleshoot issues on study; oParticipate in huddles to ensure daily tasks areassigned to team members and are executed to the expected standards; oAssist with data quality checking and queryresolution. Orient volunteers to the study and the unitincluding the purpose of the study, procedures, and protocol issues such astimelines for visits and restrictions on food and drink Collect, record and maintain volunteer studydata according to study-specific protocol and SOPs ensuring quality control forcontent, accuracy and completeness. Perform a variety of complex clinical proceduresincluding but not limited to ECG, sample collection, spirometry, vital signs,dose verification, cannulation and cardiac telemetry monitoring. Record, reportand interpret findings appropriately to develop study-specific database. Centrifuge, aliquot, store and log samplesappropriately. Perform routine analysis of volunteer specimensaccording to SOPs. Evaluate specimen acceptability upon receipt and during thereview of analysis results. Perform secondary review of volunteers\u2019 resultswhen required to ensure accuracy of primary result entry.Monitor volunteer safety and report adversereactions to appropriate medical personnel. Attend to volunteer needs and requirements Maintain and restock medical supplies as needed.Maintain cleanliness and sanitation of the unit. Provide training to new staff members onstudy-specific topics and new clinical skills Assist in ensuring compliancewith staff training requirements by auditing and maintaining training records.Contribute to development of employees' training plans by advising Team Leadsof continuing education requirements and opportunities. Recruit and screen volunteers for trials andmaintain volunteer database. Participate in quality and process improvementefforts to support the culture towards a high-performing and efficient team. Assist with planning related to staffing andscheduling. Assist in ensuring that work shifts are staffed as required bysourcing internal staff, booking bank or PRN staff, updating the schedulingsystem, and notifying staff of assignments. All responsibilities are essential job functions unlessnoted as nonessential (N). Qualifications REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Working knowledge of Phase I 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 MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor\u2019s degree or educational equivalent; or High school diploma and 3 years\u2019 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 Applicable certifications and licenses as required by company, country, state, and\/or other regulatory bodies PHYSICAL REQUIREMENTS Use of telephone and face-to-face communication requiring accurate perception of speech Use of keyboard requiring repetitive motion of fingers Frequent mobilization around the facility Occasional lifting and moving objects weighing up to 10 lbs\/4.5 kg EEO Minorities\/Females\/Protected Veterans\/DisabledDid You Know?We know that meaningful results require not only the right approach but also the right people . Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA\u2122. Organization :USA04 - US - CTS Job :Phase 1
Website : https://www.quintilesims.com
Quintiles and IMSHealth have merged together to form the new QuintilesIMS. Each wanting to bring something new to customers, we deliver integrated information and technology solutions to drive healthcare forward. QuintilesIMS has approximately 50,000 employees conducting operations in more than 100 countries, dedicated to helping our clients improve their clinical, scientific and commercial results. As a global leader in protecting individual patient privacy, QuintilesIMS uses healthcare data to deliver critical, real-world disease and treatment insights.