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Senior Clinical Research Associate, Oncology – Francophone (Eastern Canada), IQVIA

Internal Job Description

· 3 years of experience in follow-up;

· BASIC FUNCTIONS:

Participates in the preparation and execution of Phase I to IV clinical trials. Oversees the progress of clinical investigations by conducting interim site assessment, initiation, and closure visits. Monitors clinical trials in accordance with clinical best practices and procedures established by IQVIA and its sponsors. Works closely with the Clinical Trial Director (CTD) and/or the lead CRA to ensure that follow-up activities are conducted in accordance with study requirements. The lead RCAF may also act as the lead CRA.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE POSITION:

• · Participates in the investigator recruitment process. Conducts on-site evaluation visits of potential investigators. Evaluates the site's ability to successfully manage and conduct the clinical study.
• · Collaborates with ISS to coordinate activities with the site in preparation for the launch of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with the ISS and site staff to obtain regulatory approval (IRB/IEC) of study-specific documents.
• · Conducts study initiation activities, reviews protocol, regulatory issues, study procedures with site staff, and provides training at the end of FERC; monitoring activities and study closure activities.
• · Trains site staff on the EDC system and verifies the site's computer system.
• · Helps resolve any issues to ensure compliance with site file audits in collaboration with the ISS.
• · Ensures adherence to good clinical practices, investigator integrity, and adherence to study procedures through on-site monitoring visits. Performs validation of source documentation as per sponsor's requirements. Prepares monitoring reports and letters according to the timelines defined in IQVIA SOPs using templates and reports approved by IQVIA or the Sponsor.
• · Documents the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor. Conducts inventory of investigative products. Ensures the return of unused materials to the designated location or verifies destruction, if applicable.
• · Examines the quality and integrity of clinical data through (1) an internal review of the FIU's electronic data and (2) an on-site source verification. Works with sites to resolve data queries.
• · May review protocols, FERCs, study manuals, and other related documents, as requested by the clinical trial authority and/or the lead CRA.
• · Serves as the primary contact between IQVIA and the investigator; coordinates all correspondence; Ensures timely transmission of clinical data with study site and technical reports as requested.
• · Conducts study closure visits in accordance with the study-specific clinical follow-up plan, including reconciliation and disposition of final investigation products, reconciliation of site study files, resolution of data queries up to database locking, and resolution of outstanding action items.
• · Attends and participates in investigators' meetings for assigned studies.
• · Is allowed to request site audits due to data integrity issues.
• · Attends study, business, department, and outside related meetings as required.
• · Ensures that internal and study-related trainings are completed in accordance with IQVIA and/or study's schedules; DECs should always be updated with relevant site updates/contacts.
• · Ensures that study deliverables are completed according to IQVIA Biotech and study schedules.
• · Conducts field assessment visits and field training of RCAF I, II and other core RCAs.
• · Serves as a mentor for CRA assistants and those who are new to the business and/or study.
• Performs other duties, as requested.
• You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE SENIOR CRA POSITION:

The Senior Clinical Research Associate will be able to perform the following duties:

· Participates in the investigator recruitment process. Conducts on-site evaluation visits, as appropriate, of potential investigators. Evaluates the site's ability to successfully manage and conduct the clinical study.

· Collaborate with ISS 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 the ISS and site staff to obtain regulatory approval (IRB/IEC) of study-specific documents.

· Conducts study launch activities, review with site staff protocol, regulatory issues, study procedures, and provide training at the end of the eCRF; follow-up and closure activities of the study.

· Attends and participates in investigators' meetings for assigned studies.

· Trains site staff on the EDC system and checks the site's computer system.

· Assist in troubleshooting issues to ensure compliance with site file audits in collaboration with the ISS.

· Ensures adherence to clinical best practices, investigator integrity, and adherence to study procedures through follow-up site visits. Performs validation of source documentation as per sponsor's requirements. Prepares monitoring reports and letters according to the timelines defined in IQVIA SOPs using templates and reports approved by IQVIA or the Sponsor.

· Documents the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor. Conducts inventory of investigative products. Ensures the return of unused materials to the designated location or verifies destruction, if applicable.

· Examines the quality and integrity of clinical data through (1) an internal review of the FRC's electronic data and (2) an on-site source verification. Works with sites to resolve data queries.

· May review draft protocols, FERCs, follow-up reports and letters, study manuals and others, prepare study-related documents and templates, as requested by the CTA and/or ED.

· May serve as the primary contact between IQVIA Biotech and the investigator; coordinates correspondence; Ensures timely transmission of clinical data with study site and technical reports as requested.

· Assists the DEC and/or DE in reviewing project budgets, tracking costs, potential overruns and proposing/implementing cost-effective solutions.

· Assists study management in identifying and generating scope changes.

· Conducts study closure visits in accordance with the study-specific clinical follow-up plan, including reconciliation and disposition of the final investigational product, reconciliation of study files from the site, resolution of data queries up to database locking, and resolution of outstanding action items.

· Is allowed to request site audits due to data integrity issues.

· Attends study, business, department, and outside related meetings as required.

· Ensures that internal and study-related trainings are completed in accordance with IQVIA and/or study's schedules; CTAs should always be updated with relevant site updates/contacts.

· Ensures that study deliverables are completed according to IQVIA and study schedules.

· May conduct field assessment visits and field training of RCAF I, II and senior RCAF.

· Serves as a mentor for ARC assistants and those who are new to the business and/or study.

· Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of a potential CRA.

· Reviews and approves CRA travel expenses and timesheets.

· Performs other duties, as required.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE TECHNICAL CDS POSITION:

The technical DEC will be able to perform one of the following tasks for oncology studies:

· Bring together treatment-discharged and out-of-study patients.

· Generate and review various IL2 reports.

· Work closely with the CRDC to ensure that data is further reviewed and that discrepancies are documented.

· The Technical CTA may participate in the review of the CRDC and assist in the review of the patient's profile, if necessary.

· Additional follow-up may be required following the CRDC review.

KNOWLEDGE, SKILLS AND ABILITIES:

· Strong knowledge of the clinical research process, including working knowledge of clinical trial functional areas and medical terminology.

· Four years or more of experience in oncology and/or medical device.

· Experience in monitoring and/or coordinating clinical trials is mandatory.

· Excellent written and verbal communication skills to express complex ideas to study staff in research and clinical institutions.

· Demonstrated ability to form strong functional relationships.

· Excellent presentation, organizational, and interpersonal skills.

· Ability to interact with staff hierarchy to coordinate/execute study activities.

· Ability to manage multiple priorities across multiple and complex trials.

· Ability to reason independently and recommend specific solutions in a clinical setting.

· Ability to work independently, prioritize and work in a matrix team environment.

· Ability to mentor and co-monitor other CRAs as required.

· Knowledge of electronic data entry, 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, lease an automobile.

· For the role of the Technical CTA, the CRA must have a thorough understanding of IQVIA systems with the ability to learn more.

PHYSICAL REQUIREMENTS:

· Very limited physical effort required to perform normal tasks

· Extensive use of the telephone and face-to-face communication requiring accurate speech perception

· Heavy keyboard use requiring repetitive finger movements

· Regular sitting for long periods of time

MINIMUM RECRUITMENT STANDARDS:

· BS/BA/BSc (or equivalent) in one of the life sciences or healthcare fields (Ph.Aut., RN and other) and a minimum of four (4) years of experience in site monitoring/management is required; or an equivalent combination of education, training and experience.

· Previous experience in a clinical research organization (CRO) preferred.

· Previous project team leadership experience preferred.

· Working knowledge of budget management preferred.

· Must be able to travel domestically and internationally approximately 65% to 85%.

· Valid driver's license.

· Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint and the use of a laptop.

RANKING (U.S.):

This position is classified as exempt under the Fair Labor Standards Act; Employees are not eligible for overtime pay.

Level of Employment:

143

Primary Display Location:

Kirkland, Canada (CAKRKR, 37.5, H)

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Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 2 years of year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA est fière d'être un employeur offrant l'égalité des chances et nous nous engageons à créer un environnement diversifié et inclusif. Nous ne pratiquons aucune discrimination fondée sur la base de tout motif de discrimination interdit applicable, y compris, mais sans s'y limiter, la race, la religion, la couleur, l'origine nationale, le sexe, l'orientation sexuelle, l'âge, l'état civil ou le handicap. Des accommodements pour les candidats avec un handicap sont disponibles à toutes les étapes du processus de recrutement, sur demande. Si vous avez une déficience physique ou un handicap nécessitant un accommodement, nous vous encourageons à le divulguer lors du processus de recrutement afin qu'IQVIA puisse vous accommoder de manière appropriée.

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé.  IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez Travailler chez IQVIA | Emplois et carrières chez IQVIA

IQVIA is proud to be an equal opportunity employer and we are committed to creating a diverse and inclusive environment. We do not discriminate on the basis of any applicable prohibited ground of discrimination, including but not limited to race, religion, colour, national origin, gender, sexual orientation, age, marital status, or disability. Accommodations for applicants with disabilities are available at all stages of the recruitment process upon request. If you have a physical impairment or a disability that requires an accommodation, we encourage you to disclose this during the recruiting process so that IQVIA can appropriately accommodate you.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.Learn more at https://jobs.iqvia.com