Clinical - Clinical Research Coordinator

Tribe513 | The Onyx Group•Five Forks, SC

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
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
A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task.
This position requires excellent time management and communication skills and confidentiality.

Nice To Haves

Blood Draw experience preferred

Responsibilities

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 making sure all individuals are up to date on all aspects of a clinical trial.
Oversee organization and workflow of trials with meticulous attention to detail and ordering of priorities.
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 through written progress notes.
Have working knowledge of protocol including background, rationale, and description of investigational drug/device.
Thorough knowledge of Inclusion/Exclusion criteria with Investigator available for questions.
Coordinate and document in-service training for appropriate staff.
Submit all regulatory documents and correspondence to regulatory personnel in a timely manner.
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 accurately and per qualifications and delegation by PI.
Collaborate with attending Investigator and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.
Participate in weekly site meetings.
Communicate with other professionals via phone, email, and face-to-face meetings to make sure the whole clinical trial team is consistently aware of any relevant information and issues.
Ability to communicate effectively both verbally and in writing with advanced interpersonal communication skills. This includes the 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.