Clinical Research Associates (CRAs) for Oncology Clinical Trials in the United States

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

11 April, 2022

If you need Clinical Research Associates (CRAs) for clinical trials in the U.S., please contact us at info@sofpromed.com 

Are you a biotech company looking for Clinical Research Associates (CRAs) for oncology clinical trials in the United States?

Sofpromed provides CRAs to biotechnology companies conducting phase I-IV cancer trials in the U.S. via an independent contractor model.

Please keep on reading to learn how our CRAs can help you with your oncology study and how you can hire them.

Senior Clinical Research Associates (CRAs) with More than 10 Years of Experience

All our CRAs are senior clinical research professionals with more than 10 years of experience in managing oncology clinical trials in the United States.

Our team of CRAs has solid industry expertise, as they have worked with small biotech companies and the world’s largest pharma across the U.S. for several years. 

As seasoned expert CRAs, they can work independently in coordination with the clinical trial Sponsor, ensuring high-quality site management as well as remote and onsite monitoring.

Deep and Extensive Oncology Expertise

In addition to being part of an oncology-focused CRO, Sofpromed’s CRAs have dedicated their careers to managing oncology trials. They are highly qualified specialists in monitoring cancer studies of any phase. 

Our US CRAs have in-depth knowledge in the following tumor types (among others):

  • Breast cancer
  • Non-small cell lung cancer (NSCLC)
  • Ovarian cancer
  • Melanoma
  • Gastrointestinal cancer
  • Biliary tract cancer
  • Pancreatic cancer
  • Colorectal cancer
  • Prostate cancer
  • Acute myeloid leukemia
  • Lymphoma
  • Non-Hodgkin’s lymphoma 

Remote and Onsite Monitoring at Top US Cancer Centers

Sofpromed’s CRAs have long-lasting experience in working with top US cancer centers, including the following: 

  • MD Anderson Cancer Center, Houston
  • Memorial Sloan Kettering Cancer Center, New York
  • Dana-Farber Cancer Institute, Boston
  • Mayo Clinic, Rochester and Phoenix
  • The Johns Hopkins Hospital, Baltimore
  • Cleveland Clinic, Cleveland
  • Massachusetts General Hospital, Boston
  • The Mount Sinai Hospital, New York

Thanks to the experience obtained with these and other sites, our CRAs have established good relationships with local staff, which facilitates the process of starting new studies.

Established Relationships with US Cancer KOLs

As a result of their many years of experience working with US oncology hospitals and clinics, Sofpromed’s CRAs have already established strategic relationships with medical oncologists at several US sites. Many of these doctors are key opinion leaders (KOLs) in specific tumor types. Therefore, depending on the tumor under investigation, Sofpromed can quickly involve these KOLs in the study proposed by the Sponsor. These KOLs can act as coordinating investigators, principal investigators, or as members of Independent Data Monitoring Committees (IDMCs).

Quick Site Feasibility and Selection

The abundant oncology trial experience gained by Sofpromed and its CRAs permits fast cancer site feasibility and selection. Since we know which sites and investigators do well at recruiting patients with certain tumor types, we can easily recommend good hospitals to the study Sponsor. This valuable knowledge speeds up the study start-up process and shortens overall project timelines.

Onsite Monitoring Across the US

Sofpromed’s CRAs are strategically located across the US territory, from East to West, covering most States, so the most convenient CRA can be assigned to the study depending on site location. This CRA allocation based on geographic area increases the efficiency of clinical operations and significantly reduces the cost of onsite monitoring visits. 

Our CRA Full Service List

The services provided by our US CRAs include the following:

  • Participate in the identification of potential investigators and clinical sites; conduct pre-study site visits, collect and review data; participate in the final selection of investigators and study sites.
  • Assist with the implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools.
  • Conduct clinical trial site initiation visits; advise and train site personnel on sponsor and regulatory requirements for study conduct; participate and/or conduct site meetings and multicenter investigator meetings.
  • Conduct site monitoring visits and follow-up to identify problems and issues, and to ensure that all clinical aspects of studies are being carried out in accordance with applicable regulations and guidelines.
  • Review on-site records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies, and provide remedial training and/or initiate corrective action if required.
  • Perform drug/device accountability at clinical sites (i.e. pharmacies).
  • Perform remote and/or onsite source data verification (SDV).
  • Provide support to sponsor/CRO data management teams, by reviewing Electronic Data Capture (EDC) system queries and obtaining resolution from sites.
  • Assist in the close-out of clinical studies by identifying issues for review and/or follow-up; assemble necessary documents, conduct site close-out visits, review completeness and accuracy of files.

Contract Flexibility: Get the Specific Level of Service You Need

One of the most important advantages of hiring Sofpromed’s CRAs is the high level of contracting flexibility that the trial Sponsor gets. As a biotech company, you can hire our CRA services via an independent contractor model, in which you can indicate the specific duration and workload to be included in the contract. For example, you may want to hire a CRA to work full time on an oncology trial for 6 or 12 months, or you may just need the CRA to conduct one remote or onsite monitoring visit at a specific site every 3 months. Our contracting model is flexible and can be perfectly adapted to your particular needs. 

How Can I Contract Sofpromed’s CRAs?

Hiring Sofpromed’s CRAs is a simple process. Firstly, get in touch with one of the Sofpromed’s representatives to explain your CRA requirements, including the tumor types included in your clinical trial, the foreseen resource dedication (monthly hours), and the specific services needed (e.g. site management, remote/onsite monitoring). Then, we will send you the CV of the best candidate for your study and the corresponding hourly rate.

If you need Clinical Research Associates (CRAs) for clinical trials in the U.S., please contact us at info@sofpromed.com

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com