Ensure Health Authority and IRB/IEC submission and approval. Ensure all auxiliary documents ... direct authority Ability to embrace and communicate change Well organized / solid project ...
Ensure Health Authority and IRB/IEC submission and approval. Ensure all auxiliary documents ... direct authority Ability to embrace and communicate change Well organized / solid project ...
Irb Director Remote information
What does an IRB director do when working remotely?
An IRB Director who works remotely oversees the operations of an Institutional Review Board (IRB), ensuring that research involving human subjects complies with ethical standards and federal regulations. Their responsibilities include reviewing research proposals, coordinating virtual IRB meetings, communicating with researchers, and maintaining documentation. Working remotely, they use digital tools to manage submissions, facilitate communication, and ensure the board’s activities are conducted efficiently and in compliance with all applicable laws.
What are some common challenges faced by a remote IRB director, and how can they be effectively managed?
As a remote IRB Director, one of the main challenges is maintaining clear communication and oversight with board members, researchers, and compliance staff across different locations and time zones. Adopting robust digital collaboration tools and establishing regular virtual meetings can help ensure everyone stays aligned and informed. Additionally, upholding rigorous ethical standards and regulatory compliance remotely requires well-documented processes and an emphasis on thorough training. Staying proactive with updates on federal regulations and fostering a strong virtual team culture are also key to success in this role.
What are the key skills and qualifications needed to thrive as an IRB director in a remote setting, and why are they important?
To thrive as a remote IRB Director, you need expertise in research ethics, regulatory compliance (e.g., FDA, OHRP regulations), and a strong background in human subjects protection, typically supported by an advanced degree in a relevant field. Familiarity with electronic IRB management systems, regulatory databases, and certifications like CIP (Certified IRB Professional) are commonly expected. Outstanding leadership, attention to detail, and effective virtual communication are crucial soft skills for managing teams and ensuring protocol adherence remotely. These competencies are vital to uphold ethical standards, safeguard research participants, and efficiently oversee review processes in a distributed work environment.
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Clinical Research Manager III (Remote Position)
Fort Worth, TX • On-site, Remote
Contractor
Re-posted 25 days ago
Job description
Company Description
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Job Description:
Accountable for all aspects of assigned clinical trials. Lead the Clinical Trial Team, who is responsible for planning, conducting and reporting of clinical trials. Author robust protocols with scientific rigor and quality. Trial conduct must be efficient, with seamless execution and timely reporting.
Lead and matrix manage the global multidisciplinary Clinical Trial Team who is responsible for planning, conducting and reporting on all clinical trials within Development, including trials for Proof-of-Concept and Registration. Each Clinical Manager leads 2 or more clinical trial teams for studies of medium to high complexity in support of one or more projects.
Contribute medical/scientific/feasibility input for the development of the protocol synopsis. Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into the protocol.
Independently ensure quality and timely execution of a clinical trial within timeline and budget
Forecast trial resource needs. Accountable for the development, management and tracking of trial budget. Obtains approval for trial budget. Accountable for accuracy of trial information in all trial databases and tracking systems. Manages ongoing study budget.
Write scientifically rigorous protocols aligned with the approved protocol synopsis.
Lead clinical trial team to select countries and sites.
Ensure investigational product supply.
Ensure Health Authority and IRB/IEC submission and approval.
Ensure all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality and available.
Define clinical outsourcing specifications for clinical trial vendors (labs, reading centers, etc.). Work with Procurement to identify vendors.
Define scope of work and contract requirements for clinical trial vendors. Oversees vendor conduct of tasks.
Ensure implementation of standard data collection modules, where possible or obtains approval for deviation.
Track trial progress and milestones.
Resolve issues within the clinical trial team or elevates issue to appropriate teams and governance committee.
Ensure ongoing data quality review (masked review).
Ensure data cleaning and database lock.
Ensure reporting of results to Management, Clinical Team and Core Team.
Arrange and lead Clinical Trial Team Meetings and responsible for writing minutes
Active participant of the Clinical Team under the leadership of the Clinical Lead (CL).
Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, briefing packets, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.
Qualifications
Skills:
Ability to establish clear directions and set stretch objectives
Aligns and energizes team members behind common objectives
Excellent people and communication skills
Organizational awareness to operate in a cross-functional team
Builds support from others in situations with no direct authority
Ability to embrace and communicate change
Well organized / solid project management skills
Customer/Quality Focus
Scientific thinking allowing to identify bias and validity issues
Establishes effective relationships with customers and gains their trust and respect
Conduct of clinical studies
Experience in running clinical studies independently without significant supervision
Ability to proactively identify issues, respond appropriately and provide guidance for pro-active resolution
Solid understanding of the clinical trial regulations (GCP, FDA, EMA, ICH, ISO etc.)
Education:
University degree in Medical Science or equivalent education required. Advanced degrees (e.g., MD, PhD, O.D., PharmD) are preferred.
9+ years in clinical research or relevant scientific, industry, therapeutic or geographic experience
Relevant industry experience includes experience in planning and execution of clinical studies in various phases and geographies
Solid understanding of the integrated development process of medical devices and/or pharmaceuticals
Ability to establish clear directions and set stretch objectives
Aligns and energizes team members behind common objectives
Excellent people and communication skills
Organizational awareness to operate in a cross-functional team
Builds support from others in situations with no direct authority
Ability to embrace and communicate change
Well organized / solid project management skills
Customer/Quality Focus
Scientific thinking allowing to identify bias and validity issues
Establishes effective relationships with customers and gains their trust and respect
Conduct of clinical studies
Experience in running clinical studies independently without significant supervision
Ability to proactively identify issues, respond appropriately and provide guidance for pro-active resolution
Solid understanding of the clinical trial regulations (GCP, FDA, EMA, ICH, ISO etc.)
Education:
University degree in Medical Science or equivalent education required. Advanced degrees (e.g., MD, PhD, O.D., PharmD) are preferred.
9+ years in clinical research or relevant scientific, industry, therapeutic or geographic experience
Relevant industry experience includes experience in planning and execution of clinical studies in various phases and geographies
Solid understanding of the integrated development process of medical devices and/or pharmaceuticals
Additional Information
Warm Regards
Neha Sharma
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3437 | Fax: 973.998.2599
Neha Sharma
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3437 | Fax: 973.998.2599
About Artech
Sourced by ZipRecruiter
Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).
Industry
Recruiting and staffing services
Company size
10,000+ Employees
Headquarters location
Morristown, NJ, US
Year founded
1992