Site Readiness

1 week ago

New York, United States Actalent Full time
Description:

•Develop awareness of regulatory legislation, guidance and practice in the assigned countries with the support from senior staff •Assist senior staff to compile, prepare, submit and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements •Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable) •Perform a review of final submission documents as applicableOrganize communication related to the submissions/outcomes within Labcorp as applicableEscalate study issues appropriately and in a timely fashion •Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable) In Country specific tasks (Global) •Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner •Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance •Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines •Update study documents when there are changes in study personnel/study amendments •Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp ready for an audit at any time •Update status reports, applicable logs and tracking systems as applicable for the projects with input provided by senior staff •With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements •May support / assist the contract negotiation process under supervision of an experienced colleague or line manager •Proactively identifying and escalating to Submission Leads any risk to meeting deliverables •Notify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists

Skills:

Contract, clinical research, contracts, negotiation, Regulatory

Top Skills Details:

Contract,clinical research,contracts,negotiation

Additional Skills & Qualifications:

Experience: Minimum 0 - 2 years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job •Working knowledge of ICH, RA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process Education: Level of education preferred (if required or experience level which may be substituted for level of education). Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.). •University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

Experience Level:

Intermediate Level
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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