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What is a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA)?

CRCs (Clinical Research Coordinators) and CRAs (Clinical Research Associates) are professionals who play vital roles in clinical trials. CRCs are responsible for managing the day-to-day operations at the clinical site, including recruiting participants, collecting data, and ensuring protocols are followed. CRAs, on the other hand, typically work for sponsors or contract research organizations and are tasked with monitoring clinical trial sites to ensure compliance with regulatory requirements and study protocols. Both roles are essential for the successful conduct and integrity of clinical research.

What are the key skills and qualifications needed to thrive as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA)?

To thrive as a CRC or CRA, you need a solid understanding of clinical research protocols, regulatory guidelines, and data management, typically supported by a bachelor’s degree in life sciences or a related field. Familiarity with electronic data capture (EDC) systems, Good Clinical Practice (GCP) certification, and clinical trial management software is highly valued. Exceptional organizational skills, attention to detail, and strong communication abilities help professionals excel in managing studies and collaborating with stakeholders. These competencies are essential for ensuring trial integrity, regulatory compliance, and the successful execution of clinical research projects.

What are common challenges Clinical Research Associates (CRAs) face when working with multiple clinical trial sites, and how can they manage them?

Clinical Research Associates (CRAs) often manage several clinical trial sites simultaneously, which can present challenges such as coordinating schedules, ensuring consistent protocol adherence, and maintaining clear communication among diverse site teams. Effective CRAs use strong organizational skills, frequent site visits, and robust digital tools to track progress and address issues promptly. Building strong relationships with site staff and fostering open lines of communication are also key to resolving problems quickly and ensuring trial integrity.

What is the difference between Crc Cra vs Clinical Research Associate?

AspectCrc CraClinical Research Associate
CertificationsTypically requires GCP, ICH, and industry-specific certificationsSame certifications are often required, including GCP and ICH
Work EnvironmentWorks in clinical trial sites, hospitals, or research centersWorks at trial sites, monitoring progress and compliance
Industry UsageCommonly used in pharmaceutical and biotech industriesWidely used in clinical research across healthcare sectors

Both Crc Cra and Clinical Research Associate roles involve monitoring clinical trials, ensuring compliance with regulations, and coordinating with research sites. The main difference lies in terminology used by different organizations or regions, but their responsibilities, certifications, and work environments are very similar.

Can a CRC become a CRA?

A Clinical Research Coordinator (CRC) can transition to a Clinical Research Associate (CRA) with experience in clinical trial processes, monitoring, and regulatory compliance. Gaining relevant certifications, such as those from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA), can facilitate this career progression. Typically, a CRA role requires more oversight and knowledge of regulatory requirements than a CRC position.

What are popular job titles related to Crc Cra jobs in Wisconsin?

For Crc Cra jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Crc Cra jobs in Wisconsin look for?

The top searched job categories for Crc Cra jobs in Wisconsin are:

Crc Cra jobs near you

Monitoring Excellence Academy - Oncology / CART/ Ophthalmology - CRA 1 - Central or West

Fortrea

Montreal, WI • Remote

$80/hr

Full-time

Posted 10 days ago

Key responsibilities

  • Perform all aspects of study site monitoring, including routine monitoring, site close-out, and study file maintenance.

  • Ensure study staff are properly trained and adhere to protocol and regulatory requirements, including informed consent procedures.

  • Complete SAE reporting, review CRFs, generate queries, and resolve data discrepancies.

Fortrea rating

8.3

Company rating: 8.3 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

29th of 75 rated research

Job description

Fortrea's Monitoring Excellence Academy is hiring!! We are seeking strong, Oncology or Ophthalmology Clinical Research Coordinators or Research Nurses with 2+ years of current experience. Must have 2+ years of Oncology, CAR T or Ophthalmology experience as a CRC or research nurse.Open to various Central or West coast hub locations around the US and French Speaking candidates in Montreal, Canada. Must be willing to travel 65-70%.

WHAT YOU WILL DO

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Responsibilities:

  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
  • Responsible for all aspects of site management as prescribed in the project plans
  • General On-Site Monitoring
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
  • Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
  • Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
  • Assist with training of new employees, eg. co-monitoring
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) and may act as a local client contact as assigned
  • Perform other duties as assigned by management

Requirements

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
  • 2+ years as a Study Coordinator or Research Nurse in specified therapeutic areas
  • Oncology or Ophthalmology experience is strongly desired ; CAR T a plus
  • 60-70% overnight travel

The important thing for us is you are comfortable working in an environment that is:

  • Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
  • Changing priorities constantly asking you to prioritize and adapt on the spot.
  • Teamwork and people skills are essential for the study to run smoothly.
  • Technology based. We collect our data directly into an electronic environment.

Work Environment:

  • Work is performed in an office environment with exposure to electrical office equipment.
  • Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

  • Ability to sit for extended periods and operate a vehicle safely.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.
  • Target Pay Range: $80-90K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

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