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Job Title : Clinical Research Coordinator |
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| General Summary of duties :
Perform clinical research activities and investigations for drug, device
and registry projects. Develop standard operating procedures for research
activities. Requires direct patient contact both inpatient and outpatient
office records. Provide subject and/or family education. Perform follow up
assessments and clinical data for study projects. Maintain databases, help
develop office web page and patient education newsletter. |
| Supervision Received :
Reports to Practice Administrator and Medical Director. |
| Supervision Exercised :
Supervises all applied department. |
Essential Functions :
- Evaluate new protocols for feasibility at the site including protocol,
study materials, Investigator Brochure and informed consent form. Assists
in determining adequate subject population. Reviews/evaluates timelines
set by protocol. Assess resources necessary to do the study.
- Attend Investigator Meetings and clarify necessary
items with sponsor.
- Coordinates site visits and monitoring visits. Work with
monitors during visits to resolve queries.
- Maintains all required regulatory documents including confidentiality
agreements, contracts/budgets, and IRB communication for research
projects. Prepares site for conducting the study including training, file
organization and maintaining current licensures/ CV for study personnel.
- Maintains drug/device accountability logs.
- Responsible for subject screening and informed consent
process. Responsible for assuring most current consent form is
being used and is correctly signed.
- Performs/monitors data collection and submission. Coordinates
subject follow up visits/contact.
- Managing laboratory procedures such as drawing labs,
processing, packaging and shipping specimens.
- May render direct nursing care to patients in accordance with
institutional policies. Must maintain privileges with
organization.
- Maintaining payment schedules to Health System and patients.
- Maintaining documentation of payments for Cardiovascular
Research Foundation.
- Completing study closeout activities at the end of the study.
- Help to recruit new studies.
- Professionally represent the organization to all
people/organizations. Protocol evaluation and feasibility including
budget evaluation.
- Clinical trail preparation involving the planning, assembling
and instruction of the trail team, development and evaluation of
patient information and informed consent forms and patient
recruitment.
- Regulatory and ethical submissions and procedures and
communicating with relevant authorities.
- Implementation of the clinical trial from initiation through the
stages of development, SOPs, tools, organization facilities and
licenses.
- Coordination and management of the clinical trail, communication with
sponsor and authorities, visit coordination, sampling, time management and
product accountability.
- Development of source documents, data collection and management, filing and
archiving, overseeing monitoring visits and query resolution.
- Close-out of the clinical trial, audit preparation, communication with
authorities and other disciplines involved and completing financial obligations.
- Other assigned duties in accordance with the needs of the organization.
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Education : RN with valid license and graduate degree preferred.
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Experience : Related field of study with 2-5 years of clinical
research experience and current licensure preferred.
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Requirements :CRC,SOCRA,GCP and Phlebotomy certification is
preferred.
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Knowledge :Knowledge of professional nursing theory, regulations and
practices to give and evaluate patient care. Knowledge of common safety
hazards and precautions to establish/maintain a safe work environment. |
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Skills : Skill in applying and modifying the principles, methods and
techniques of professional nursing to provide ongoing patient care. Skill
in identifying problems and recommending solutions. Skill in
preparing/maintaining records, writing reports and responding to
correspondence.
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Abilities :Ability to encourage motivation, innovation and high
performance. Ability to delegate responsibility and manage staff. Ability
to communicate effectively and clearly.
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Physical/Mental Demands : Requires sitting and standing associated
with a normal office environment. Some bending and stretching requires. |
Environmental/Working conditions : Normal office environment.
Occasional evening or weekend work.
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Note :This description is intended to provide only basic
guidelines for meeting job requirements. Responsibilities, knowledge,
skills, abilities and working conditions may change as needs evolve.
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 your Resume to
HRmanager@drvora.com
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