VTS Associate Project Management Analyst

Job Profile Summary    

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.

Responsibilities
     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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience
Typically requires a minimum of 2 - 5 years of experience.

Knowledge
Requires broad knowledge of operational systems and practices gained through experience and/or education.

Education    
Bachelor's Degree      
High School Diploma or equivalent                 

Additional Work Experience     
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             

Skills and Abilities 
    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        


Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions


Physical Demands
Use hands and fingers to handle and manipulate objects and/or operate equipment.                 
Perform unaided lifting of objects, please list the amount of weight that would be lifted, along with the frequency required.                    

The above information on this description has been designed to indicate the general nature and level of work performed.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job.  While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.