Clinical Research Associate Sponsor-dedicated
4 days ago
**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 regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- 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 site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
**Qualifications**
- High School Diploma or equivalent Degree in scientific discipline or health care preferred.
- Requires at least 1 year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- 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 Arabic and 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.
-
Riyadh, Saudi Arabia IQVIA Full time**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...
-
Riyadh, Ar Riyāḑ, Saudi Arabia IQVIA Full time 36,000 - 72,000 per yearJob OverviewPerform 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 FunctionsPerform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...
-
Riyadh, Ar Riyāḑ, Saudi Arabia IQVIA Full time $40,000 - $80,000 per yearJob OverviewPerform 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...
-
Clinical Research Associate
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia CTI Clinical Trial Services Full time $60,000 - $120,000 per yearClinical Research Associate (level dependent on experience) Job Purpose/SummaryAs a CRA you will be responsible for the successful conduct of clinical trials and serve as the main contact for the investigative site by representing CTI in a professional manner. What You'll DoConduct evaluation, initiation, monitoring and close out visitsAssist with...
-
Riyadh, Saudi Arabia IQVIA Full time**Role Summary**:Manage the execution of the assigned clinical studies, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed, ensuring quality deliverables on time and in accordance with SOPs, policies and practices. **What we Offer**: - Excellent salary and benefits package - Company car...
-
Riyadh, Saudi Arabia IQVIA Full time**Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...
-
Riyadh, Ar Riyāḑ, Saudi Arabia IQVIA Full timeJob OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...
-
Riyadh, Ar Riyāḑ, Saudi Arabia IQVIA Full timeRiyadh, Saudi Arabia | Full time | Hybrid | R1508170Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team...
-
Clinical Research Associate- Dammam
3 days ago
Riyadh, Ar Riyāḑ, Saudi Arabia CLINLIA Full timeCompany DescriptionClinLia is a leading Saudi Clinical Research Organization (CRO) focused on supporting and managing clinical research across various therapeutic areas. With a commitment to advancing clinical research in Saudi Arabia in alignment with the 2030 vision, ClinLia plays a key role in putting the Kingdom on the map for clinical trials and...
-
Clinical Project Manager, Sponsor-dedicated
3 days ago
Riyadh, Ar Riyāḑ, Saudi Arabia IQVIA Full timeJob OverviewProject Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies...
