Clinical Researcher (Expert)

Clinical Researcher (Expert)
  • $44.42 - $26.81 per Hour
    HOUR
  • Temporary
  • New JerseWhippany NJ, US New JerseWhippany MORRIS US 07981
Job Ref: JO000107986
Sector: Science
Date Added: 03 November 2020


Clinical Researcher (Expert)

Description:

POSITION/TITLE: Senior Clinical Research Associate
DEPARTMENT/TEAM DESCRIPTION
The hiring is for the US Monitoring group of the Translational Studies Operation department
POSITION SUMMARY
The Senior Clinical Research Associate (SR CRA) is a site management and monitoring expert on the extended Global Study Team. The SR CRA is accountable and responsible for all aspects of site management and monitoring activities for assigned TSO Phase I and Phase IIa studies and clinical investigator sites or phase I units.• The Sr CRA is responsible for the overall quality of the assigned studies by using relevant IT systems, among other tools.• This requires an in-depth knowledge of the drug development process including monitoring and site management, local and international regulations, Good Clinical Practices (ICH – GCP), drug safety requirements, data management processes and investigator grant parameters.• The overall purpose of the SR CRA is to verify that:1. The rights and well-being of human subjects are protected.2. The reported trial data are accurate, complete, and verifiable from source documents.3. The conduct of the trials is in compliance with the approved protocol/amendment(s), with GCP, and with the applicable regulatory requirements.
POSITION DUTIES & RESPONSIBILITIES
MONITORING
1. SR CRA is responsible for Monitoring, using available IT systems, tools, and expertise to ensure the Investigator and site staff meet all aspects of study delivery and commitments from site selection through close out. This includes, but is not limited to, ensuring the following key areas of focus:
• Adequate site resources for conduct of the study including staff, facilities, and equipment.
• Proper training and qualifications for all site staff participating in the study. This includes the preparation of SIV training slides.
• Proper control, storage, dispensation, patient compliance, and accountability of Investigational Product.
• Appropriate Regulatory and Legal approvals are in place throughout the conduct of the study.
• Site enrollment commitments are on track with enrollment plan.
Position Duties and Responsibilities - List the primary job duties and responsibilities using headings and then give examples of the types of activities under each heading.
• Identify six to eight duties and responsibilities for the position, including how tasks are accomplished and anticipated results.
MONITORING
1. SR CRA is responsible for Monitoring, using available IT systems, tools, and expertise to ensure the Investigator and site staff meet all aspects of study delivery and commitments from site selection through close out. This includes, but is not limited to, ensuring the following key areas of focus:
• Adequate site resources for conduct of the study including staff, facilities, and equipment.
• Proper training and qualifications for all site staff participating in the study. This includes the preparation of SIV training slides.
• Proper control, storage, dispensation, patient compliance, and accountability of Investigational Product.
• Appropriate Regulatory and Legal approvals are in place throughout the conduct of the study.
• Site enrollment commitments are on track with enrollment plan.
• Data integrity, quality, and timely resolution of all queries.
• Documentation and timely resolution of all action items which could negatively impact study deliverables.
• All adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).
2. Responsible for preparing and conducting onsite and/or remote monitoring visits according to monitor plan, including complete reporting and follow up for all monitoring visits.
3. Rigorous regulatory guidelines exist to ensure overall patient safety, related to reporting of serious or unexpected adverse drug reactions. The SR CRA is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting as well as monitoring ongoing compliance.
QUALITY
4. Due to the highly regulated clinical trial environment, the SR CRA must proactively identify potential issues and assist the project team in the development of site Corrective Action/Preventative Action Plans (CAPAs) if required. The SR CRA ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
5. As a key contributor to the paper or electronic Trial Master File (TMF) and study documents at the country and site level, the SR CRA ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File with an expectation to be Inspection Ready at all times. In addition, the Sr CRA is responsible for Investigator Site file preparation following sponsor SOPs. This includes the preparation of Study specific forms (e.g. Source Data Identification checklist, Drug accountability forms).
6. The incumbent is a member of the audit/regulatory inspection team and a key contributor to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.
OVERSIGHT
7. As a result of their experience and expertise, the SR CRA may be a mentor and role model for new or less experienced CRAs on process, study, technical, and behavioral competencies. The SR CRA may review monitoring reports to ensure high quality performance within an assigned project. The SR CRA may also conduct co-monitoring or oversight visits to mitigate risks and ensure the quality and reliability of study data and processes. The SR CRA may participate in Expert Working Groups for Global SOPs, training or process improvement initiatives or other activities at the discretion of the TSO Head of Monitoring.
COLLABORATION
8. The SR CRA works in close collaboration with the Study Manager (StM), Clinical Trial Specialist (CTS), Study Data Manager (SDM) and Study Lead Monitor (SLM), if applicable, for internally monitored and outsourced clinical trials. This includes escalation of operational issues or potential issues.
9. The Sr CRA may be involved in the development or review of the Monitoring Plan and other study documents (e.g. Study Protocol or Patient Informed Consent).
10. The Sr CRA supports regulatory and country start-up activities and may coordinates quality initiatives.
11. The Sr CRA is involved in the development of the eCRF by performing the Screen review and UAT (user acceptance test
REQUIREMENTS/PREFERENCES
Education Requirement(s): Bachelor's Degree
Skill & Competency Requirements:
Awareness & understanding of cultural and regional operational differences§ Oral presentation & interpersonal skills§ Decision making§ Issue resolution§ Planning and organization, time management, prioritization§ Effective written and verbal English communication skills § Travel to sites, study meetings, local and international level up to 80%§ eCRF experience, preferably RAVE system

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
03/12/2020 12:00:00
USD 44.42 44.42
Contact Consultant:
Jennifer Law

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