CSMC 8270300 Orthopedic – Spine Medical Staff Clinical Research Coord I PR 31684 Monetti R09 0.25

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.  Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.  Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.  Presents study information at regular research staff meetings.  Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

PRIMARY DUTIES AND RESPONSIBILITIES

Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

Schedules patients for research visits and procedures.

In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

Schedules and participates in monitoring and auditing activities.

Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

Notifies direct supervisor about concerns regarding data quality and study conduct.

Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Maintains research practices using Good Clinical Practice (GCP) guidelines.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Participates in required training and education programs.

SKILLS, KNOWLEDGE, AND ABILITIES

Regulatory – Ability to use discretion and maintain privacy, confidentiality, or anonymity; Maintains strict patient confidentiality according to HIPAA regulations and applicable law. 

Regulatory – Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations; Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). 

Communication – Ability to convey and receive written/verbal information to and from various audiences in different formats; Establishes effective working relationships with cross-functional teams.

Educational Requirements:

Assoc. Degree/College Diploma – Minimum
Bachelor’s Degree (Science, Sociology, or related) – Preferred

Licenses:

Certification in Clinical Research (SOCRA, ACRP) – Preferred

Experience:

2 years of directly related experience – Minimum

Physical Demands:

Lifting, standing, walking

: CSMC 8270300 Orthopedic – Spine Medical Staff Clinical Research Coord I PR 31684 Monetti R09 0.25