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CRISPR Therapeutics
Boston, MA, United States
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular an
Job Source: CRISPR TherapeuticsScorpion Therapeutics
Boston, MA, United States
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and da
Job Source: Scorpion TherapeuticsScorpion Therapeutics
Boston, MA, United States
Job Summary: We are seeking a highly motivated and detail-oriented individual to join our team as a Clinical Trial Associate/Sr. Clinical Trial Associate. As a Clinical Trial Associate at Scorpion Therapeutics, you will play a vital role in the planning, coordination, and execution of our early phase clinical trials, ensuring compliance with regul
Job Source: Scorpion TherapeuticsCRISPR Therapeutics
Boston, MA, United States
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular an
Job Source: CRISPR TherapeuticsScorpion Therapeutics
Boston, MA, United States
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and da
Job Source: Scorpion TherapeuticsMonte Rosa Therapeutics, Inc
Boston, MA, United States
Overview: We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and is an opportunity to significantly contribute to the growth and development of a top-tier Biotech company. The CTA position is focused on providing support associated with the plan
Job Source: Monte Rosa Therapeutics, IncDeciphera Pharmaceuticals
Waltham, MA, United States
Job Description The Role: We are seeking a Clinical Trial Associate (CTA) to assist and provide support to the members of the clinical operations project team in order to facilitate the management of the clinical trial processes, including planning and execution of clinical trials. The CTA assists in supporting the conduct of trials and may be re
Job Source: Deciphera PharmaceuticalsINTELLECTT INC
Waltham, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: INTELLECTT INCWaltham, MA, United States
100% Remote - Clinical Trial Associate
Contract
Onsite - 3-4 days
Experience required:
4+ years as CTA.
Sponsor / Pharma experience
Experience with late stage study close out.
ADDITIONAL DETAILS:
Majority of studies are late phase - iii, iv, registry studies, etc.
Therapeutic area is Rare Disease.
Focus on close out activities and TMF compliance.
Work ethic/initiative
Sponsor side experience
Depth of site close out experience
Summary of Key Responsibilities:
This position will manage the administrative aspects of clinical trials at every stage of the
process (study documents, implementing and maintaining databases, coordinating payments and supplies to research units).
Study Documentation: Prepares / assembles study documentation and support the Clinical
Project Manager in ensuring the compliance of the clinical trial with internal SOPs and regulations.
TMF Management: Handles and maintains electronic/ paper TMF and electronic internal repository according to ICH/GCP guidelines and European standards. Responsible for periodic quality checks and general oversight of TMF as well as TMF reconciliation after study completion. Support the CTM in TMF audit and inspection readiness activities.
10% Clinical Trial Supplies: Collaborates with Clinical Project Manager, Clinical Supply Unit and QA in order to manage activities related to Clinical Supplies. Manages study related payment
procedures. Interacts with external providers during study conduct (CROs, monitors and,
occasionally, with investigators and Hospital personnel).
Budgeting/RFPs: Provides input for budget development and checks monthly costs invoiced to client based on planned study activities vs actual. Participate in the completion and review of the RFPs in collaboration with the Clinical Project Manager.
Organizes and/or participates Kick-off Meetings, Study Design Meetings, and phone-conferences
with the CROs for the continuous update on clinical studies. Ensure appropriate meeting minutes are prepared and filed in TMF.
Requirements:
4+ years of experience as a Clinical Trial Associate
Sponsor side work experience
Late stage study experience is required.
Study Closeout is required.
Experience with eTMF systems is required (Veeva being the most common).
Team player, shows initiative
Excellent at relationship building and accountability.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. "
Email Alert for Clinical Trial Associate jobs in Waltham, MA, United States
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