IQVIA Clinical Research Coordinator, Qcare (Clinic based in Wilmington, NC) in Wilmington, North Carolina
What is Qcare? Qcare is IQVIA’s novel site-services provider organization that leverages deep trial management expertise to assist investigators and improve study awards and subject recruitment.
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.
Provide clinical research support to investigators toprepare for and execute assigned research studies, including:
Review study protocols, Case Report Forms (CRFs),other study-specific documents, and electronic data capture systems usedto record clinical research data;
Attend all relevant study meetings;
Collect and submit regulatory/ethics documentation asrequired by the FDA and other regulatory bodies governing the conduct ofclinical research;
Recruit and screen patients for clinical trials andmaintain subject screening logs;
Orient research subjects to the study, including thepurpose of the study, procedures, and protocol issues such as timelinesfor visits;
Design and maintain source documentation based onprotocol requirements;
Schedule and execute study visits and perform studyprocedures;
Collect, record and maintain research subject studydata according to study protocol and SOPs, preserving quality control forcontent, accuracy and completeness;
Handle lab testing and analysis, including preparationof specimen collection tubes and lab logistics;
Monitor subject safety and report adverse reactions toappropriate medical personnel;
Correspond with research subjects and troubleshootstudy-related questions or issues;
Participate in “huddles” to confirm daily study tasksare assigned to team members and are executed to the expected standards;
Assist with study data quality checking and queryresolution.
Perform a variety of complex clinical researchprocedures including but not limited to ECG, sample collection,spirometry, vital signs, dose verification, cannulation and cardiactelemetry monitoring.
Record, report and interpret study findingsappropriately to develop a study-specific database.
Assist investigator in verifying that research studyobjectives are met on time, within budget and according to applicableprotocol requirements, clinical research regulations and qualitystandards.
Provide training to new investigator site staff memberson study-specific topics and requirements. Assist inmaintaining adherence to investigator site staff training requirements byauditing and maintaining training records.
Prepare for and attend study monitoring visits, studyaudits, and regulatory inspections with clinical research regulatoryagencies.
Assist research site with coverage planning related tostaffing and scheduling for research projects.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Working knowledge of clinical trials
Working knowledge of the principles of Good ClinicalPractices (GCP)
In-depth knowledge of departmental, protocol andstudy-specific operating procedures, consent forms, and study schedules
Skill in carrying out required clinical procedures suchas intravenous catheter insertion and spirometry testing
Good skill in using MS Windows and Office applicationssuch as Access, Outlook and Word
Excellent interpersonal skills
Ability to pay close attention to detail
Ability to establish and maintain effective workingrelationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree or educational equivalent; or Highschool diploma and 3 years’ relevant work experiencein a clinical environment or medical setting, e.g., medical assistant,assistant nurse, laboratory technician; or equivalent combination ofeducation, training and experience
Applicable certifications and licenses as required bycompany, country, state, and/or other regulatory bodies
Use of telephone and face-to-face communicationrequiring 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 10lbs/4.5 kg
EEO Minorities/Females/Protected Veterans/Disabled
USA-North Carolina-Research Triangle Park