What are the responsibilities and job description for the Laboratory Technician-FT position at Evolution Research Group?
About Company
Who is ERG?
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340 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
The Laboratory Technician is responsible for assisting with document management, protocol related clinical assessments of research subjects, laboratory functions, and assisting in tasks of the Clinical Research Coordinators as it relates to the conduct of clinical trials. Completes all duties under the direction of the Site Director or designee. Maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Intake Assistant is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.
PRN-hours will vary, need to be flexible
Responsibilities
Who is ERG?
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340 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
The Laboratory Technician is responsible for assisting with document management, protocol related clinical assessments of research subjects, laboratory functions, and assisting in tasks of the Clinical Research Coordinators as it relates to the conduct of clinical trials. Completes all duties under the direction of the Site Director or designee. Maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Intake Assistant is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.
PRN-hours will vary, need to be flexible
Responsibilities
- Maintain tenants of good customer service when interacting with subjects, staff, and representatives of sponsors or CROs.
- Clinical skills include phlebotomy, vital sign measurements, and performing ECGs.
- Collect demographic, medical, and medication history.
- Complete safety assessments
- Work closely and collaboratively with Director of Clinical Operations, Clinical Research Coordinators, Sub-Investigator, and Principal Investigator.
- Enter data as appropriate for multiple Electronic Data Capture platforms as well as respond and resolve queries that may arise.
- Meet defined goals established in conjunction with site leadership.
- Study, learn, and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable.
- 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.
- Education and experience
- High School Diploma or equivalent
- Experience in a medical setting/ training and certification as a Medical Assistant/CNA
- Requirements
- Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
- Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
- Good organizational and interpersonal skills
- Attention to detail.
- Knowledgeable in medical terminology
- Excellent communication skills (interpersonal, written, verbal)
- Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)