Clinical - Clinical Research Coordinator

Tribe513 | The Onyx Group•Spartanburg, SC

1d•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
Strong clinical skills
Computer skills for communication
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
Able to multi-task
Excellent time management and communication skills
Confidentiality

Nice To Haves

Blood Draw experience

Responsibilities

Conducting Phase II, III and IV clinical trials
Oversight of assigned clinical trials
Informed Consent Process
Medical Record Review
Protocol compliance/documentation
Patient relations
Sponsor relations/communication
Investigational Product/Drug Administration
Collaboration with QA
Trains other clinical trial associates
Oversee organization and workflow of trials
Navigate and address sponsor and study issues to resolution
Perform clinical responsibilities, such as blood draws, processing, vaccine administration
Maintenance of organized, complete study charts, and legible, accurate research documentation
Have working knowledge of protocol including background, rationale, and description of investigational drug/device
Thorough knowledge of Inclusion/Exclusion criteria
Coordinate and document in-service training for appropriate staff
Submit all regulatory documents and correspondence to regulatory personnel
Identify protocol problems and inform TCR Research Team of problems limiting recruitment and work on strategies to overcome these problems
Maintain detailed drug accountability
Conduct ordering of all protocol required follow-up labs, tests, procedures, and medications
Collaborate with attending Investigator and Principal Investigator to report serious adverse events
Participate in weekly site meetings
Communicate with other professionals via phone, email, and face-to-face meetings
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
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