IQVIA Contract- Sr. Clinical Research Associate, Surgical/Gastrointestinal (South East, Home-based) IQVIA Biotech in Columbia, South Carolina
Independent Contractor Opportunity for a Sr. Clinical Research Associate, with inpatient Surgical and /or Gastrointestinal experience to cover four South East sites, (Alabama; Florida, North Carolina, South Carolina).
IQVIA Biotech, a division of IQVIA, delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones.
POSITION TITLE: Contract - Senior Clinical Research Associate (CRA)
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
Trains site staff on the EDC system and verifies site computer system.
Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
Assists with, and attends, Investigator Meetings for assigned studies.
Authorized to request site audits due to data integrity concerns.
Attends study-related, company, departmental, and external meetings, as required.
Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
Ensures all study deliverables are completed per IQVIA Biotech and study timelines
Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
Serves as mentor for junior CRAs and those new to the company and/or study.
Performs other duties, as requested.
KNOWLEDGE, SKILLS AND ABILITIES:
Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
Four+ years of oncology experience and/or medical device.
Experience in monitoring and/or coordinating clinical trials required.
Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
Demonstrated ability to form strong functional relationships.
Excellent, presentation, organizational and interpersonal skills.
Ability to interact with all levels of staff to coordinate/execute study activities.
Ability to handle several priorities within multiple, complex trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to work independently, prioritize, and work within a matrix team environment.
Ability to mentor other CRAs and co-monitor, as required.
Knowledge of electronic data capture including basic data processing functions.
Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
Able to qualify for a major credit card, rent an automobile
For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.
Very limited physical effort required to perform normal job duties
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
MINIMUM RECRUITMENT STANDARDS:
BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.
Prior Clinical Research Organization (CRO) experience preferred.
Experience working on Gastrointestinal inpatient/surgical studies.
Prior project team leadership experience preferred.
Working knowledge of budget management preferred.
Must be able to travel domestically and internationally approximately 65%-85%.
Valid driver’s license
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
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 firstname.lastname@example.org to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.