Clinical - Clinical Research Coordinator

Tribe513 | The Onyx Group•Greer, SC

22h•Onsite

About The Position

The Clinical Research Coordinator will be primarily responsible for conducting Phase II, III and IV clinical trials within internationally accepted standards of knowledge and understanding of the research process and related regulations. A lead study coordinator will have oversite of assigned clinical trials conducted at Tribe Clinical Research, under the direction of the Primary Investigator and Site Lead. Since this is primarily a patient contact position, it requires an outgoing, friendly personality and someone who enjoys working with a diverse population of people. To understand the inclusion/exclusion requirements of protocols, a strong understanding of medical terminology is required. Strong clinical skills required and computer skills for communication.

Requirements

CMA Certification or willingness to complete
Blood Draw experience preferred
Medical and Clinical Research Terminologies
Excellent verbal, written & interpersonal skills
Exceptional attention to detail and accuracy
Data Management and Informatics
Adhere to Principles of Ethical Research Standards
Highly organized individual
Continuous learning mindset
Ability to communicate effectively both verbally and in writing with advanced interpersonal communication skills.
Ability to perform computer-based work on a regular basis.
Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.
Ability to read and understand the protocol, including any amendments, to ensure familiarity with study procedures and an understanding of the potential risks and side effects of the investigational product.
Ability to interact daily with physicians, nurses, study monitors and other sponsor representatives, administrators and other employees, community resources, patients and their families and significant others.
Highly organized, utilize excellent verbal and written communication and be able to multi-task.
Excellent time management and communication skills and confidentiality.

Nice To Haves

Outgoing, friendly personality
Enjoys working with a diverse population of people.

Responsibilities

Conducting Phase II, III and IV clinical trials.
Oversight of assigned clinical trials under the direction of the Primary Investigator and Site Lead.
Managing the Informed Consent Process.
Performing Medical Record Reviews.
Ensuring Protocol compliance/documentation.
Managing Patient relations.
Managing Sponsor relations/communication.
Administering Investigational Product/Drug.
Collaboration with QA.
Training other clinical trial associates.
Overseeing organization and workflow of trials.
Addressing and resolving sponsor and study issues.
Performing clinical responsibilities, such as blood draws, processing, vaccine administration.
Maintenance of organized, complete study charts, and legible, accurate research documentation through written progress notes.
Maintaining working knowledge of protocol including background, rationale, and description of investigational drug/device.
Understanding Inclusion/Exclusion criteria.
Coordinating and documenting in-service training for appropriate staff.
Submitting all regulatory documents and correspondence to regulatory personnel.
Identifying protocol problems and informing the TCR Research Team of problems limiting recruitment and working on strategies to overcome these problems.
Maintaining detailed drug accountability.
Ordering of all protocol required follow-up labs, tests, procedures, and medications.
Collaborating with attending Investigator and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel.
Participating in weekly site meetings.
Communicating with other professionals via phone, email, and face-to-face meetings.
Performing computer-based work on a regular basis.
Understanding the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.
Reading and understanding the protocol, including any amendments, to ensure familiarity with study procedures and an understanding of the potential risks and side effects of the investigational product.
Interacting daily with physicians, nurses, study monitors and other sponsor representatives, administrators and other employees, community resources, patients and their families and significant others.