QUALIFICATIONS/JOB REQUIREMENTS:
· Successful completion of formal/clinical training program(s), such as those required of registered nurses, licensed practical nurses, CNAs, emergency medical technician, R.T., and certified medical assistants or equivalent job experience.
· No less than two year of clinical experience involving patient care in a healthcare or research environment in the role of a CRC.
· Ability to interpret, and perform clinical, laboratory and diagnostic tests.
· Ability to function independently without close supervision, and to consistently exercise discretion and the highest level of good clinical and other professional judgment.
· Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.
· Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances) with keen and acute attention to detail.
· Strong written, verbal, and interpersonal skills.
· Strong self-motivation skills and the ability to be a “self-starter,” coupled with the capability to work as a team player, as well as independently, while simultaneously managing a variety of clinical research study related projects.
· Ability to meet and satisfy flexible, dynamic work schedules and be “on-call” if necessary.
· Successful completion of IATA training concerning the handling and shipping of hazardous goods and materials, followed by recertification every two years following initial certification. ICH/GCP knowledge and expertise needed.
· Provide administrative support to the Clinical Research Director and to Study Investigators engaged in the performance of clinical research studies. Tasks required to fulfill this responsibility include interpretation of clinical, laboratory and diagnostic tests; applying such interpretations to advise the Clinical Research Director and to Study Investigators concerning management of clinical research studies.
· Design and maintain organizational tools to ensure that each clinical research study is conducted accurately and in compliance with good clinical practice guidelines.
· Research and apply all federal Food and Drug Administration (FDA) regulations and guidelines applicable to clinical research studies to ensure compliance with federal law.
· Interpret clinical, laboratory and diagnostic tests for each clinical research study to which a Study Coordinator is assigned. Such interpretations must be accurate and in compliance with research study protocol to maintain the integrity of the study.
· Coordinate and supervise direct patient/study participant care associated with various clinical research studies. Tasks required to fulfill this responsibility include, but are not limited to, reacting to and providing recommendations based on new/unanticipated adverse events; performing electrocardiograms, taking and interpreting vital signs; properly identifying and obtaining relevant laboratory specimens, receiving the results of laboratory tests associated therewith, and recording those tests; coordinating and assisting with physical examinations; and recommending changes in required medications.
· Data entry into CTMS system
· Recruit and screen potential patient/study participant’s compliance with each clinical research study protocol’s inclusion and exclusion criteria. Obtain proper written informed consent from each potential study participant, prior to participation in the study.
· Maintain accurate and complete case histories for each study participant that record and reflect all observations and data collected from those participants during clinical trials. Successful completion of this responsibility requires the exercise of independent judgment as to what information is relevant for inclusion in case histories.
· Utilize computer software applications to enhance workflow and study activity efficiency. Successful completion of this responsibility requires knowledge of the requirements of each clinical research study and exercising independent judgment to identify appropriate software applications.
WORKING CONDITIONS:
· Medical office environment, specializing in Pulmonary, Sleep, and Internal
Medicine practice. Direct contact with patients, staff and physicians. Exposure to communicable diseases and body fluids, hazardous substances and other conditions common to clinic environment. Exposure to emergency situations.
Availability morning, evenings and weekends. CRCs may work up to 50 hours a week, depending on the trials the site is working on and the needs of the study.
ESSENTIAL FUNCTIONS:
· Ability to lift, push, manipulate equipment and patients which requires strength, gross motor and fine motor coordination. Ability to administer prescribed treatments. Ability to perform CPR and venipuncture. Ability to stand for long periods of time.
TRAVEL:
· There may be an instance when staff may be asked to temporarily work at another office. Your flexibility is appreciated when this situation arises.
Job Type: Full-time
Schedule:
· Monday to Friday
· Weekend availability