Research Coordinator

RENAL MEDICINE ASSOCIATES LTD•Albuquerque, NM

About The Position

Renal Medicine Associates in Albuquerque, NM is hiring a full-time Clinical Research Coordinator to join our. team. REQLIRED JOB KNOWLEDGE AND SKILLS: 1. Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors. 2. Knowledge of Medical terminology. 3. Knowledge of good clinical practice, FDA, OHRP, HIPPA policies. 4. Familiarity with Microsoft office, Word etc. 5. Previous work with CRF’s, IWRS and EDC. 6. Excellent organizational skills to independently manage work flow. 7. Ability to prioritize work quickly and appropriately. 8. Ability to multi-task. 9. Meticulous attention to detail. PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS: 1. Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. 2. Schedules study participant appointments and serves as the patient liaison to the PI and other participating Physicians. 3. Reviews and comprehends each assigned protocol including study proceedings and timelines, Inclusion and Exclusion criteria, confidentiality and privacy protections. 4. Working closely with PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process. 5. Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits. 6. Completes case report forms and extract data from patient’s chart and responds to data clarification requests in a timely manner. 7. May attend Investigator meetings requiring travel and report pertinent information back to research team members. 8. Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, Renal Medicine Associates and sponsoring agency policies and procedures. 9.Maintains all clinical trial related logs and reports all the protocol deviations to PI, CRO’s, sponsors and IRB in a timely manner. 10. Coordinates and facilitates monitoring and auditing visit. Notifies, collaborates with PI and appropriate institutional officials of external audits and to respond to any audits findings and implement approved recommendations. 11. Works collaboratively with the other members of the clinical research team member and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data. 12. Performs specimen collection, processing and shipment of biological specimen duties. 13.Arranges secure storage of study documents that will be maintained according to institutional policy or for the length of time whichever is longer. 14. Establishes and organize study files, including but not limited to , regulatory binders, study specifics source documentation and other materials as required. 15. Promotes the ethical conduct of research as defined within the Renal Medicine Associates Handbook. 16. May perform other job related duties as requested or requires.

Requirements

Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
Knowledge of Medical terminology.
Knowledge of good clinical practice, FDA, OHRP, HIPPA policies.
Familiarity with Microsoft office, Word etc.
Previous work with CRF’s, IWRS and EDC.
Excellent organizational skills to independently manage work flow.
Ability to prioritize work quickly and appropriately.
Ability to multi-task.
Meticulous attention to detail.
Minimum of 1-3 years of experience in Clinical Trials

Nice To Haves

Specimen collection, processing and shipping, ECG skills preferred.
Bilingual a plus

Responsibilities

Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Schedules study participant appointments and serves as the patient liaison to the PI and other participating Physicians.
Reviews and comprehends each assigned protocol including study proceedings and timelines, Inclusion and Exclusion criteria, confidentiality and privacy protections.
Working closely with PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.
Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
Completes case report forms and extract data from patient’s chart and responds to data clarification requests in a timely manner.
May attend Investigator meetings requiring travel and report pertinent information back to research team members.
Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, Renal Medicine Associates and sponsoring agency policies and procedures.
Maintains all clinical trial related logs and reports all the protocol deviations to PI, CRO’s, sponsors and IRB in a timely manner.
Coordinates and facilitates monitoring and auditing visit.
Works collaboratively with the other members of the clinical research team member and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
Performs specimen collection, processing and shipment of biological specimen duties.
Arranges secure storage of study documents that will be maintained according to institutional policy or for the length of time whichever is longer.
Establishes and organize study files, including but not limited to , regulatory binders, study specifics source documentation and other materials as required.
Promotes the ethical conduct of research as defined within the Renal Medicine Associates Handbook.
May perform other job related duties as requested or requires.