Clinical Research Regulatory Specialist Job at Dermatologists of Central States
Company Overview
Dermatologists of Central States (DOCS) is one of the largest and most established dermatology practices in the nation. With more than 186 providers within 80+ locations in 7 states, we have been serving patients for over 40 years. At DOCS, we strive to put the patient first with an emphasis on medical, surgical, and cosmetic dermatology. We provide easy access to high quality dermatologic care in an environment that is consistently friendly, convenient, courteous, and caring.
Summary
Complete and maintain regulatory files for clinical research studies. Assist staff and physicians with clerical duties and maintain overall organization while following regulations according to standards of Good Clinical Practice, HIPAA and OSHA.
Hours:
Monday 10:00 or 12:00 to 8:00
Tuesday 8:30-5:00
Wednesday 8:30-5:00
Thursday 8:30-5:00
Friday 8:30-1:00 or 3:00
Tuesday 8:30-5:00
Wednesday 8:30-5:00
Thursday 8:30-5:00
Friday 8:30-1:00 or 3:00
Job Responsibilities
- Responsible for compliance of regulatory procedures, including study preparation and maintenance which includes interim reviews and study closure reports, SAE reporting and tracking, memo to file reports, maintenance of regulatory, correspondences and visit binders and completion of study closure file.
- Maintains good communication and follow through when working with IRB’s tracking the regulatory process to assure timely completion of regulatory approvals, changes and reporting.
- Maintains good communication and follow through when working with sponsors and / or CRO’s during the conduct of the clinical trial.
- Maintains record archiving and destruction records, following regulatory requirements. Assists in the final close-out storage of clinical trial records.
- Participate in educational training seminars on all topics of clinical research.
- Maintains updated CV’s and “Clinical Trial Experience” data sheets.
- Prepares for monitoring visits and assists during the visits with regulatory issues.
- Assists in required contract invoicing of trial budgets. Requests checks for patient compensation and tracks to patient.
- Performs drug dispensing as may be required per protocol.
- Follows and maintains GCP in the regulatory processes.
- Maintain computer system with support from vendor.
- Covers the duties of the receptionist when he / she is not in the clinic.
- Assist receptionist with maintenance of data base for advertising and recruitment of patients for trials.
- Answer telephone and schedule appointments, and follow-up on missed appointments.
Minimum Qualifications
- High School diploma or equivalent certificate
- Prior experience in medical office
- Ability to learn related center tasks and be of assistance to management and physicians
- Clinical Trials experience
- Understanding of clinical trials rules and regulations
- Self-motivated to achieve the highest patient care and customer service standards
- Knowledge of ICD-10 and CPT coding (preferred)
- Familiarity with the ModMed EMA EMR (preferred)
- Thorough understanding of HIPAA law
- Team player
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status
INDAD22
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