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Job Summary and Responsibilities:
The Clinical Research Coordinator, RN is responsible for coordinating and overseeing clinical operations of a clinical trial and participates in assessing, planning, implementing and evaluating patient care in clinical research studies. The Clinical Research Coordinator, RN carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials.
1. Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential.
2. Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.
3. Acts as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
4. In collaboration with the principal investigator, reviews studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
5. Reviews study with principal investigator to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
6. Recruits and evaluates study patients, schedule appointments and interviews.
7. Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
8. Reviews medical records for potential study patients and ensures that medical records include documentation of all laboratory test results and procedures and progress of study patients, following guidelines set forth by the protocol sponsors.
9. Instructs potential study patients, designated caregiver, physicians, nurse clinicians and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments and side effects.
10. Assists investigator with consent process assuring study patients understand clinical trials and obtains written informed consent.
11. Educates study patients concerning informed consent procedures, HIPAA authorization.
12. Documents study patient's medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.
13. Performs nursing assessments and monitors study patient's progress during clinical trials; Tracks study patient's response by documenting on toxicity flow sheet, medication flow sheet and nurses' progress notes.
14. Evaluates and develops study patient education materials and gives study patient and/or designated caregiver instructions on drug administration and other medical information; creates study specific calendars for study patients.
15. Plans for study patient's appropriate care under the direction of a physician or advanced practice nurse.
16. Notifies principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
17. Reports all serious adverse events to sponsor and IRB of record according to established timelines.
18. Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams.
19. Performs and/or oversees a variety of clinical duties that may include but not limited to: EKGs, processing/shipping of blood serum, urine and communicates results to PI and/or APN.
20. Act as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel.
21. Maintains accurate, complete, up-to-date records on each patient participating in a clinical trial protocol.
22. Ensures study patient's clinical trial related activities are billed appropriately and reconciles drug study account records with research finance personnel.
23. Prepares and assists for sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.
24. Develops case report forms and/or databases for physician initiated studies as needed.
25. Assists the principal investigator in preparing for publication. Works with analysts and assists with queries related to data to evaluate the significance of collected data.
26. Provides education to all departments and clinical areas where study is performed.
27. Attends research meetings and conferences as required.
28. Participates in staff meetings and in-service education of nursing and medical staff.
29. Adheres to the standards identified in the Medical Center's Organizational Competencies.
Working Conditions: Lifts a minimum of 5 lbs., pushes and pulls a minimum of 5 lbs. and stands a minimum of 6 hours a day.
Education, Knowledge, Skills and Abilities Required:
1. Graduate of a NLN/AACN accredited program in nursing.
2. 2-5 years clinical nursing experience.
3. Adheres to the American Nurses Association standards.
4. Mandatory education on human subjects research.
Education, Knowledge, Skills and Abilities Preferred:
2. FDA regulatory, IND reporting, Microsoft or similar Office Suite, oncology or clinical research.
Licenses and Certifications Required:
1. California State Professional Registered Nurse License.
Licenses and Certifications Preferred: