IQVIA Clinical Research Coordinator, Qcare (Clinic based in Wilmington, NC) in Wilmington, North Carolina

Description:

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.

PURPOSE

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

  • 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).

Qualifications:

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

PHYSICAL REQUIREMENTS

  • 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

Job Field:

Clinical Operations

Primary Location:

USA-North Carolina-Research Triangle Park

Other Location(s):

USA-North Carolina-Wilmington