Location
Hialeah, FL | United States
Job description
Job Details
Job Location LOC003 CPMI Clinical Pharmacology Miami - Hialeah, FL
Description Job Title: Screening Manager Location: CPMI About us: ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.
Job Description: Under the direction of the Site Director the Screening Manager is responsible for overseeing the screening department, compiling daily and weekly screening reports, reporting screening and enrollment information to Clinical Study Managers and executive team, training new screening staff, making the screening schedule, and collaborating with the recruitment & clinical departments. Responsible for accurately documenting all information obtained throughout the clinical research process.
Responsibilities: - Oversee the day-to-day operations of the Screening Department.
- Participate in study planning (screening, admission, and out-patient visits) process with all Department Heads.
- Ensure screening staff is trained in all current and upcoming protocols.
- Communicate with the study teams to ensure the informed consent forms and all screening documents are prepared and available for screening.
- Ensure the accurate completion of screening study documents and prompt delivery of completed documents to the study team.
- Work with recruitment and study teams to create the screening schedule on a weekly basis.
- Ensure completion of the enrollment logs for Pre-Screening/Screening/Screen Failures daily for all studies.
- Regularly attend training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
- Conduct the informed consent process, per Standard Operating Procedures, as needed.
- Screen and conduct study procedures, as designated on the Delegation of Authority Log, as needed.
- Follow up daily on all laboratory results.
- Maintain infection control safety standards when performing job responsibilities.
- Available to answer questions for other members of the staff, study patients or medical staff, as necessary.
- Assist with QA and QC activities on studies.
- Obtain Principal Investigator signatures on necessary documents.
- Perform annual performance review on screening staff
- Maintain continuous education for the screening department.
- Seek out to improve operational processes to improve the screening department and improve quality.
- Initiate off cycle staff reviews and/or disciplinary action in conjunction with Site Director and HR specialist, if necessary.
- Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.
Skills and Qualifications: - Education and experience
- Maintain current licensure, registration and/or certification within educational background.
- Maintain necessary CEU's for registration and/or certification.
- Train screening staff in duties at the clinic
- Participate in ongoing Quality Assurance Program HIPAA and Compliance Programs
- Keep up to date on all new OSHA and GCP/ICH rules and regulations
- Attend all appropriate team meetings regarding study protocols.
- Read and understand policies and procedures manuals, SOPs, and employee handbook.
- Requirements
- Certification in a clinical or allied health field with a minimum of six months experience in a medical facility.
- Customer Service experience required.
- Clinical research experience required.
- Good working knowledge of medical terminology and the clinical research process
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