Clinical Research Manager jobs in Hialeah, FL

CRC

Title: Clinical Research Coordinator 

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:

The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities:

General

• Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
• Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manage studies with direct oversight from Site Director, and Principal Investigator to ensure compliance with protocol requirements.
• Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
• Contribute to the SOP review and development as delegated by the Site Director.

Study Management

• Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
• Attend the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.
• In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
• Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
• Review and obtain informed consent from with potential study volunteer
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
• Maintain organized, accurate and complete study records
• Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
• Enter data as appropriate for protocol (paper-electronic data capture)
• In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
• Perform study close-out procedures.
• Store study records appropriately
• 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
  • High School Diploma or its equivalent; College degree preferred.
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology to communicate with physician office and laboratory staff.
  • Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
  • 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.
• Requirements
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • 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)

Qualifications