- 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.
- 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.
- 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.
-
Senior Regulatory Affairs Specialist
2 weeks ago
Golden Gate Group Forsyth, IL, United States FreelanceWorking at HOMANN means being part of a regionally rooted family business and an internationally growing food corporation. HOMANN delicatessen stands for tradition, brand quality, and good taste. As part of the Theo Müller group, HOMANN complements the portfolio in the dressings, ...
-
Clinical Research Regulatory Specialist
4 days ago
Alcanza Clinical Research Decatur, United StatesClinical Research Regulatory Specialist (Must live in Atlanta/Decatur area)Department: Quality, Regulatory & SourceEmployment Type: Full TimeLocation: Accel Research Sites - Decatur, GAReporting To: Angeline NewcombDescriptionAlcanza is a growing multi-site, multi-phase clinical ...
-
Clinical Research Regulatory Specialist
6 days ago
Alcanza Clinical Research Decatur, United StatesJob Description · Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several th ...
-
Specialist lawyers in regulatory agreement
5 days ago
beBee Handyman Allenville, IL, United States FreelanceI am in need of a Family Lawyer service in Allenville, IL with the following characteristics: Specialty of the family lawyer · Regulatory agreement · Type of service needed from the lawyer · Consultation, representation, filing of claims, ongoing court process · When do you need ...
-
Clinical Trials Regulatory Specialist II
1 week ago
Emory University Decatur, United StatesDiscover Your Career at Emory University: · Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of ...
-
LPN Clinical Support Specialist Home Health
2 days ago
AccentCare Decatur, United StatesOverview Salary: $70,000 - $78,000 Find Your Passion and Purpose as a Clinical Support Specialist Reimagine Your Career in Corporate Healthcare As a professional, you know that what you do impacts you as much as our patients and their families, and at AccentCare, we are united in ...
-
Archer Daniels Midland Company Decatur, United StatesJob Description · Transportation Compliance Documentation Specialist - Decatur, IL · DOT Compliance · This is a full-time, exempt position. · Position Summary · Specialist will report to the DOT Compliance Manager and be responsible to meet critical daily, monthly, and annual D ...
-
Archer Daniels Midland Company Decatur, United StatesJob Description · Transportation Compliance Documentation Specialist - Decatur, IL · DOT Compliance · This is a full-time, exempt position. · Position Summary · Specialist will report to the DOT Compliance Manager and be responsible to meet critical daily, monthly, and annual ...
-
Care Coordinator
1 week ago
Restore First Health Decatur, United StatesRestore First Health Restore First Health offers advanced care for chronic wounds in Georgia, New Jersey, Pennsylvania, Kansas, Colorado, Texas and Florida. Every member of our team plays an essential role to ensure we help make our patients better today and healthier tomorrow. F ...
-
Nurse Practitioner
1 week ago
Crossing Healthcare Decatur, United StatesJob Details · Job Location · Community Health Improvement Center dba Crossing Healthcare - Decatur, IL · Position Type · Full Time · Job Category · Health Care · Description · Job Summary: · The Nurse Practitioner (NP) is a primary care provider who manages uncomplicated a ...
-
Broadband Professional/Expert
3 days ago
Vyve Broadband Decatur, United StatesJob Description · Job DescriptionWho are we? · Vyve Broadband is a leading broadband Internet provider serving rural communities across 16 states. Vyve Broadband offers a range of broadband, fiber connectivity, cable television and voice services for commercial and residential cu ...
-
Healthcare Recruiter
1 week ago
Heritage Behavioral Health Center Decatur, United StatesThis NEW position at Heritage Behavioral Health Center as an Human Resources Recruiter aims to address healthcare workforce shortages and assist leaders in filling crucial vacant positions at Heritage. The HR Recruiter will play a key role by promptly screening telephone calls fo ...
-
Healthcare Recruiter
1 week ago
Heritage Behavioral Health Center Decatur, United StatesThis NEW position at Heritage Behavioral Health Center as an Human Resources Recruiter aims to address healthcare workforce shortages and assist leaders in filling crucial vacant positions at Heritage. The HR Recruiter will play a key role by promptly screening telephone calls fo ...
-
HR Recruiter
2 weeks ago
Heritage Behavioral Health Center Decatur, United StatesThis NEW position at Heritage Behavioral Health Center as an Human Resources Recruiter aims to address workforce shortages and assist leaders in filling crucial vacant positions at Heritage. The HR Recruiter will play a key role by promptly screening telephone calls for applicant ...
-
Chief Financial Officer
6 days ago
International Control Services, Inc. Decatur, United StatesJob Description · Job Description Salary: · POSITION TITLE: Chief Financial Officer · COMPANY: International Control Services · REPORTING TO: President · LOCATION: Decatur, IL · COMPANY PROFILE · International Control Services is seeking an experienced and dedicated Chief Financ ...
-
Medical/Clinical Specialist 3
3 days ago
GeorgiaGov Decatur, United States· Who we are. We protect lives.The Georgia Department of Public Health is the lead agency entrusted by the people of Georgia to proudly protect lives and promote healthy lifestyles in diverse communities statewide. We are committed to preventing disease, injury, and disability; ...
-
Hospital Outpatient Coder III
1 week ago
Emory Healthcare Decatur, United StatesOverview · At Emory Healthcare, we integrate science and caring to change the face of health care. Our team members are courageous individuals who are willing to challenge the status quo and help find solutions to complex problems. We're empowered to influence change for, and w ...
-
Chief Financial Officer
5 days ago
International Control Services, Inc. Decatur, United StatesJob Description · Job DescriptionSalary: · POSITION TITLE: Chief Financial Officer · COMPANY: International Control Services · REPORTING TO: President · LOCATION: Decatur, IL · COMPANY PROFILE · International Control Services is seeking an experienced and dedicated Chief Financi ...
-
Philips Latham, United StatesJob Title · Senior Research Scientist- Computed Tomography (CT) · Job Description · As an important member of the Computed Tomography (CT) Imaging Physics and Algorithm team, the Senior Research Scientist will develop innovative physics-based solutions/corrections and support med ...
-
Environmental Health and Safety
1 week ago
HF Sinclair Lovington, United StatesBasic Function · HF Sinclair in Lovington, NM is seeking an EHS Specialist. This position conducts high level health and safety assignments, and depending on assignment, environmental management assignments for the Department under minimal supervision. May direct or lead the wor ...
Clinical Research Regulatory Specialist - Decatur, United States - Alcanza Clinical Research
Description
Job Description
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.The Regulatory Specialist is responsible for regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance. The RC maintains communication with the IRB and reviews on-site files, folders, binders, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides training and/or initiates corrective action as required. Ensures that essential documents are organized, up to date, and in compliance with ICH/GCP guidelines and federal regulations. Assists site-focused reviews, and quality improvement activities.
Key ResponsibilitiesEssential Job Duties:
Skills, Knowledge and ExpertiseMinimum 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 preferred. Knowledge of GCP/ICH guidelines is required.
Required Skills:
Benefits