Alcanza Clinical Research

Clinical Research for All℠

Clinical Research Regulatory Specialist

Clinical ResearchClinical ResearchFull TimeRemoteTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Alabama + 10 moreAll locations: Alabama, Arizona, Florida, Illinois, Nevada, Massachusetts, Michigan, Missouri, South Carolina, Texas, Virginia

Posted

4 days ago

Salary

Not specified

Bachelor Degree2 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

**Essential Job Duties:** - Maintains regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies throughout the life of the studies. Keeps documents organized and ready for audit and ready for regulatory filings when required; - Follows the organization’s SOPs and provides guidance with staff comprehension and compliance with the SOPs; - Facilitates communication with the IRB and/or Sponsors. - Assists with and coordinates the development of clinical trial support documents. Assists with all regulatory filings. - Ensures IND safety reports are distributed to investigators and the research team for review. - Assembles reproduces, and archives (hard and electronic copies) technical documents, as appropriate for the document type. - Collaborates with the research team to facilitate overall protocol operations; - Identifies problems and issues and takes corrective action and/or escalates appropriately; - Tracks sponsor and IRB approvals and renewals; - Reports on the status of clinical trials; - Generates and reviews reports of regulatory data using appropriate systems; - Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP; - Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations; - Assists in training programs as requested; - Perform all other duties that may be requested or assigned.

Job Requirements

  • Minimum Qualifications**: A Bachelor’s degree and a minimum of 2 years experience in clinical research, OR an equivalent combination of education and experience, is required. 1+ years of regulatory experience is highly preferred. Knowledge of GCP/ICH guidelines is required.****
  • Required Skills:**
  • Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
  • Must possess strong organizational skills, attention to detail, and basic math proficiency.
  • Well-developed written and verbal communication skills.
  • Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
  • Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
  • Must be professional, respectful of others, self-motivated, and have a strong work ethic.
  • Must possess a high degree of integrity and dependability.
  • Ability to work under minimal supervision, identify problems and assist in implementing solutions.
  • Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Benefits

  • Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
  • Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Related Categories

Related Job Pages

More Clinical Research Jobs

Clinical Supervisor

Expressable

Committed to improving speech and language outcomes for children and adults with affordable, online therapy.

Clinical Research4 days ago
Full TimeRemoteTeam 11-50H1B No Sponsor

The Clinical Supervisor acts as a first-line clinical and operational leader, providing coaching and support to a team of Speech-Language Pathologists to ensure quality of care and therapist success. This role also involves direct clinical care, including evaluations and sessions, to meet organizational needs.

United States
Full TimeRemoteTeam 10,001

This role is responsible for developing, managing, and facilitating all activities related to the conduct of Company-sponsored clinical research studies, including protocol implementation, site initiation, and ensuring data collection compliance. The manager will oversee all aspects of assigned clinical projects, manage budgets, mitigate risks, and ensure timely completion of deliverables according to ICH/GCP guidelines.

United States
$100K - $130K / year
Clinical Research4 days ago
Full TimeRemoteTeam 10,001+Since 1949H1B Sponsor

The role involves providing technical, educational, clinical, and sales support to help the Region meet Cardiac Ablation Solutions sales and customer service objectives, including representing Company CAS during ablation procedures to offer troubleshooting and technical assistance. Key duties include educating and training physicians and hospital staff on AFS products and related procedures, and partnering with the Account Manager to achieve sales goals.

United States
$75K - $95K / year
Full TimeRemoteTeam 501-1,000

This role coordinates several clinical research studies focused on Parkinson Disease (PD), acting as a liaison between investigators, the community, funding agencies, and participants. Responsibilities include managing study procedures, ensuring regulatory compliance, handling participant assessments, analyzing collected data, and assisting with manuscript and grant preparation.

United States
$52.6K - $78.9K / year