Clinical Research Associate III (Field Monitor) - Midwest

We are seeking a high quality, ambitious and experienced field clinical research associate (CRA III) to support our client's boutique CRO.

This candidate must be based out of the Midwest and be able to travel up to 50% of the time. As an important member of the team, they will spend time teaching you about their organization and its aims and ambitions so that you can quickly become a productive and valued part of the team.

We need a highly motivated field CRA to support the Clinical Operations team for the successful delivery of active projects.

The field CRA supports global and regional clinical project / trial managers in the planning, designing, executing, monitoring, and reporting of clinical trials.

• The field CRA partners with internal and external team members / key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, site management, monitoring activities, essential document collection and review;
• investigative site recruitment & feasibility; FDA / GCP / ICH and regulatory compliance; data management and query resolution;
• document and SOP review; assist PM with study document / plan development and review; maintenance and close-out of in-house site management activities;

and ad hoc clinical operations support activities and tasks. You will monitor the monitoring activities of assigned clinical trials to ensure data integrity and adherence to Federal regulations, company policies and any other applicable procedures.

Essential duties and Responsibilities

To perform this job successfully, an individual must be able to perform the following :

Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “

Good Clinical Practices”, and CRA III (Field) regulatory requirements.

• Identify adverse events from research site staff and under the guidance of Clinical Affairs Management ensure appropriate reporting requirements are met.
• Verify that the data in the Case Report Forms (CRFs / eCRFs) are in agreement with the source documents (source data verification).
• Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools).
• Assist Clinical Affairs Management with development of source documents, CRFs and EDC activities
• Verify Investigational Product accountability.
• Conduct routine monitoring visits on behalf of the clinical trial sponsor with Clinical Affairs Management oversight as needed.
• Prepare sections of the study site manual of operations as delegated by Clinical Affairs Management.
• Prepare draft informed consent.
• Complete delegated clinical project deliverables per schedule.
• Assist Clinical Affairs Management to ensure audit-readiness of sponsor and investigative site files.
• Communicate relevant information to Clinical Affairs Management in a timely manner.
• Contact sites on a consistent basis to assess study compliance.
• Track screening and enrollment and identify / report issues to Clinical Affairs Management.
• Confirm that site documents match Study Master Files.
• Assist with the organization and administrative support of Investigator Meetings.
• Generate status reports process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.
• Collect and track regulatory documents (e.g., confidentiality disclosures, IRB approvals, investigator agreements, contracts, study / project annual reports and financial disclosures) to / from study sites using company specific database.
• Assist and collect documents for Data Safety Monitoring Board (DSMB) meetings under the supervision of Clinical Affairs Management.
• Able to show good judgment with interaction with external customers.
• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements Complete all training requirements on time
• Draft, revise and harmonize clinical research forms, questionnaires, trackers and templates.
• Manage vendor activities regarding enrollment materials, advertisements and other study-related materials.
• Initiate and / or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training materials, study binders, plans, study registration and other process descriptions, presentations, and reports.
• Establish and maintain the Clinical Trial Master Files (CTMF) under supervision of the Clinical Affairs Management; review the CTMF for compliance, addressing findings as needed and supporting the study team with study activities.
• Produce reports and status metrics as requested
• Travel expectations : 20-50% depending on study phase

Working hours

Hours expected are flexible and can ramp up to 40-hours per week during normal business hours depending on the various projects.

It may be necessary to work overtime during peak times and when deadlines are close.

Qualifications :

• Minimum Bachelor's degree or equivalent, in a biomedical, life science or related field of study
• A minimum of 5-8 years of experience in clinical trials in the Medical Device industry.
• Competency in ICH-GCP and a strong interest in clinical research.
• Previous experience with Medical Device and / or Pharmaceutical are studies are a plus
• Monitoring and / or co-monitoring experience is a plus
• Understand technical, scientific and medical information
• Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes, protocols, and medical terminology
• Knowledge of and / or experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability
• Strong written and verbal communication and computer literacy (e.g., Microsoft Word, Excel, PowerPoint, Outlook); strong experience utilizing CTMS, EDC, TMS, and related software
• Knowledge of ICH GCP, IRB / IEC, and local regulatory authority drug research & development regulations
• Motivated to work in a fast-paced, high-accountability environment
• May include travel up to 50% depending on scope of project

Skills

In addition, to relevant experience as a field CRA, you will need to show evidence of the following :

• Fundamental knowledge and good understanding of GCPs, FDA and International regulations and guidelines
• Experience with the clinical study development process and clinical operations logistics
• Extensive experience with monitoring clinical data both in-person at the investigational site and remote monitoring
• Attention to detail, organized, ability to work and deliver under tight deadlines with minimal supervision
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
• Demonstrated problem-solving and critical thinking skills
• Proven expertise in Google applications, MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Technical writing skills (monitoring correspondence / letters and report writing)
• Ability to communicate and relate well with key opinion leaders and clinical personnel

Key personal qualities

• Enjoy working with people
• Strong team player
• Great organizational skills
• Self-motivated with ability to demonstrate a high level of initiative
• Honest and reliable
• Positive outlook on life
• Can work under pressure and to tight deadlines
• Quick to learn and a good attention to details

What to expect

• Fast moving, fun and high-pressure environment.
• Strong team culture with a focus on delivery.
• Being part of an exciting team, which respects the individual and aims to create a culture of opportunity where you can shine.
• Experience exciting opportunities for personal growth and development.
30+ days ago