Clinical Research Coordinator (CRC) Jobs

General Summary of Duties

Provides professional nursing care and monitoring for research patients. Performs duties involved in the collection, compilation and documentation of clinical research data in accordance with established Standard Operating Procedures and current Regulatory Guidelines.

Supervision Received

Reports directly to the Clinical Research Manager.

Supervision Exercised

None

Typical Physical and Mental Demands

·    Requires full range of body motion including handling and lifting patients, manual and finger dexterity and eye-hand coordination 

·    Requires standing and walking for extensive periods of time 

·    Can support up to 100 pounds with assistance 

·    Requires corrected vision and hearing to normal range

·    Requires working under stressful conditions or working irregular hours

Typical Working Conditions

·    May be exposed to communicable diseases, toxic substances, medicinal preparations and other conditions common to a clinic environment

Knowledge

·        Knowledge of professional nursing theory and practice to give and evaluate patient care and monitoring.

·        Knowledge of organizational policies, regulations and procedures to monitor and administer patient care. 

·        Knowledge of medical equipment and instruments to monitor and administer patient care.

·        Knowledge of common safety hazards and precautions to establish a safe work environment.

Skills

·        Skill in establishing and maintaining effective working relationships with patients, medical staff, co-workers and the public.

·        Skill in conducting appropriate written, oral and telephone communications.

·        Skill in the use of basic computer software applications and associated office equipment.

·        Skill in conducting phlebotomy procedures, lab specimen collection and processing in accordance with protocol requirements.

·        Skill in the initiation and recording of 12 Lead EKGs including basic interpretation.

·        Skill in the ability to establish intravenous access as required.

·        Skill in the ability to administer oral, injectable, topical and intravenous medications as required.

Abilities

·        Ability to react calmly and efficiently in emergency situations.

·        Ability to interpret, adapt, and apply guidelines and procedures.

·        Ability to integrate new learning into the delivery of nursing care as required by individual study protocols

·        Ability to communicate clearly.

·        Ability to comprehend and follow medical records policies regarding release of information and maintains patient confidentiality.

Education and Experience

·        Graduation from an accredited school of nursing.

·        Two years of experience in clinical research setting.

·        Maintains a current curriculum vitae as required by study sponsors.

·        Demonstrates appropriate education, training and experience to perform those duties delegated by the principal investigator

Certificates / Licenses

·        Valid current license as a nurse in the state of Illinois. 

·        CPR certification.

·        Certificate of  completion in Human Research Subject Training.

Protects the Rights and Welfare of Research Subjects

·        Confer with study participants in conjunction with the primary investigator to explain the study purpose, procedures, follow up intervals, study duration, informed consent and financial features of subject enrollment.

·        Recognize the paramount importance of protecting subject safety throughout the course of the study by being sensitive to changes in subject well being, communication of changes to all vested parties including the PI, IRB, study sponsor and monitor.

·        Document and communicate Adverse Events (AEs) and Serious Adverse Events (SAEs) in a timely manner in accordance with regulatory and protocol requirements.

·        Ensure appropriate communication of diagnostic testing results to all vested parties on a timely basis.

Provides General Nursing Care to Research Subjects

·        Provides for detailed and ongoing assessment of research subjects including medication and allergy profiles, changes in well being, AEs and SAEs; and obtains vital signs, vital statistics, specimens, and diagnostic testing according to individual scope of practice and protocol requirements. 

·        Coordinates all activities related to patientsâ?? diagnostic testing, visits, and evaluations according to study timelines.

·        Collection, storage, packaging and shipping of lab specimens in accordance with study protocols.

·        Provides pager call as defined by research department.

·        Conducts patient phone calls, follow-up assessments, monitoring of AEs, SAEs and their resolution as needed.

Ensures Protocol Compliance

·        Travels to Sponsor Investigator Meetings as required for educational purposes in conjunction with study initiation.

·        Acts as a resource person for medical personnel, physicians, patients, and families participating in research activities by providing education, updated information, and supervision of protocol implementation.

·        Conducts in-service education as needed to all affiliated inpatient and clinical parties.

·        Implements research activities, in both the hospital and clinic settings, in accordance with specific protocols.

·        Coordinates the development of forms, questionnaires, checklists and procedures for the accurate implementation of the protocol at the investigative site

·        Collects and updates all documentation as required by trial sponsors, the FDA, IRBâ??s and the physicians.

·        Completes data collection and entry from appropriate sources including clinic charts, inpatient records, patient interviews, questionnaires, diagnostic tests and primary care providers as needed to provide comprehensive, accurate study data for analysis.

·        Organizes and assists with monitor visits and provides necessary source documents and documentation required for their review.  Plans sufficient time to be available for corrections as needed during the monitor visit.

Advances Professional Knowledge 

·        Attends client required meetings and participates in committees as requested.  Reviews notebooks and meeting minutes, etc.

·        Attends continuing educational classes and seminars as needed in order to remain current to changes in the field.

·        Participates in professional development activities and maintains professional affiliations as required

General Skills

·        Adheres to client policies and procedures and client Clinical Research SOPs.

·        Maintains a positive and cooperative attitude.

·        Maintains patient and staff confidentiality