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Job Description and Duties
The job duties listed below are representative and characteristic of the duties required and the level of the work performed in the job title. The duties will vary depending on employee’s knowledge and experience. The following responsibilities will be allocated to the Clinical Research Coordinator, however; duties are not limited to this listing only. Additional tasks can be assigned to the employee at the discretion of the supervisor.
Reports to Principal Investigator
Takes direction from administrators & supervisors
-Coordinates and administers the patient care functions within a research project in accordance with research protocols and the daily administration and staff supervision of the project.
-Communicates and interacts closely with Investigator.
-Oversees the planning, scheduling, and implementation of day-to-day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research subject.
-Plans and carries out programs for the recruitment, screening, enrollment, and retention of clinical research subjects and/or volunteers; instructs subjects on treatment methods and protocol.
-Performs protocol-required visit procedures and educates research participants regarding the overall research objectives and potential benefits and/or risks for participants.
-Coordinates and maintains contacts with patients, physicians, pharmaceutical companies, and/or other related parties to recruit participants and gain continuing support for the studies.
-Assist in the creation and development of Source Documents.
-Establishes appropriate data collection systems and procedures, according to pre-established research protocol; coordinates and monitors the collection, processing, shipping and recording of clinical data and/or specimen samples, as required by established study protocol.
-Enter data in electronic databases or CRFs.
-Monitors and records patient response to treatment, and communicates study data and results to investigators; maintains complete source documentation and oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate.
-Assure compliance with all requirements for Serious Adverse Event reporting, as well as submission of all required documents for review
-Administers prescribed study medications, performs phlebotomy, monitors vital signs, and/or performs other specialized medical procedures, as appropriate to the specific needs of the study and individual subjects.
-Maintain inventory of supplies.
-Identifies problems and trends, recommending procedural changes to the principle administrator and administrator.
-Directs the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high quality results and adherence to research protocols.
-Represents and promotes the objectives and activities of research studies to various internal and/or external constituencies, as appropriate.
-May oversee and guide the work of other medical and/or support staff engaged in study activities.
-Other duties as assigned.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
-Bilingual (Spanish)
-Flexibility.
-Organizing, coordinating, and multi-tasking skills.
-Ability to coordinate with main office to ensure proper documentation, adequate supplies, and patient and staff scheduling.
-Ability to observe, assess, and record symptoms, reactions, and progress.
-Knowledge of the principles and procedures of clinical research.
-Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.
-Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
-Knowledge of clinical and/or surgical facilities, instruments, and equipment.
-Ability to maintain records in an organized manner.
-Ability to recruit, evaluate and instruct clinical research subjects and volunteers.
-Ability to prepare and process laboratory samples using established protocols.
-Ability to maintain quality, safety, and/or infection control standards.
-Knowledge of accreditation and certification requirements and standards.
-Skill in the use of personal computers and related software applications.
-Ability to learn new software applications for electronic data entry.
-Knowledge of FDA regulations.
-Ability to draw blood, administer IVs, and perform standard nursing procedures.
WORKING CONDITIONS AND PHYSICAL EFFORT:
-Work is normally performed in a typical interior/office work environment from the hours of 8 AM — 5 PM; however employee must stay until work is completed.
-Some travel to investigator meetings and educational seminars required. Travel may include nights and weekends. Rarely, attendance at educational meetings, health fairs, and recruitment events may be required on evenings and/or weekends.
-Occasionally, employee may be required to be on-call nights and weekends.
-Training and working at other locations, as needed.
-Moderate physical activity. Requires handling of average-weight objects up to 25 pounds or standing and/or walking for more than four (4) hours per day.
-Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions.
BENEFITS:
-23 days of paid time off / year
o 8 company holidays
o 15 days can be used as vacation / sick / personal days
-Health and Vision insurance
-401K
-Worker’s compensation insurance
-Profit-sharing plan
Please submit resume and salary requirement. No phone calls please. Location: Houston (TMC) Compensation: commensurate with experience
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