Site Lead

Tribe513 | The Onyx Group•Spartanburg, SC

1d•Onsite

About The Position

This position will serve as a Site Lead for the Tribe Clinical Research Coordinators in multiple locations. The Site Lead will assist with the oversight of clinical trials conducted at multiple Tribe Clinical Research offices, under the direction of the Medical Director, Primary Investigators, CEO and will report to the TCR Operations Manager. The Clinical Research Coordinators provide care to patients enrolled in research studies conducted by Tribe Clinical Research. This activity is performed in collaboration with physicians at TCR and other members of the health care team. The duties include the screening of new patients who are candidates for protocols, managing them while on a protocol and providing for their follow-up care. The Site Lead will plan and conduct team education at each site.

Requirements

Currently a licensed CRC (RN/LPN) or CCMA or willingness to complete.
Knowledge of Medical and Clinical Research Terminologies.
Excellent verbal, written, and interpersonal skills.
Exceptional attention to detail and accuracy.
Data Management and Informatics.
Adherence to Principles of Ethical Research Standards.
Highly organized individual.
Continuous learning mindset.
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.
Must be highly organized, utilize excellent verbal and written communication and be able to multi-task.
Requires excellent time management and communication skills and confidentiality.

Responsibilities

Oversee workload and onboarding of clinical trial associates.
Ensure site processes adhere to TCR standards.
Perform Clinical Research Coordinator responsibilities.
Maintain respectful communication with the Team, Investigators, and Sponsors.
Provide input on study team assignments, ensuring team goals are clear and tasks are delegated appropriately.
Navigate operations and site issues.
Train, direct, and manage other clinical trial associates, ensuring they are up-to-date on all aspects of a clinical trial.
Oversee and manage coordinator workload and provide input on study assignments at multiple locations.
Oversee the organization and workflow of trials with meticulous attention to detail and prioritization.
Assist coordinators with sponsor/study issues.
Oversee the maintenance of organized, complete study charts, and legible, accurate research documentation through written progress notes.
Oversee communication with sponsors/study issues.
Oversee day-to-day operations of site operations as pertains to study schedules.
Oversee clinical responsibilities, such as blood draws, processing, and vaccine administration.
Ensure a working knowledge of protocols, including background, rationale, and description of investigational drug/device.
Ensure thorough knowledge of Inclusion/Exclusion criteria with Investigator available for questions.
Conduct TCR meetings with research staff.
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 the TCR Research Team of problems limiting recruitment, and work on strategies to overcome these problems.
Supervise the maintenance of detailed drug accountability.
Oversee the ordering of all protocol-required follow-up labs, tests, procedures, and medications accurately and per qualifications and delegation by PI.
Oversee collaboration with attending Investigator and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel within the mandated timeframe.
Maintain a good working relationship with PCA/QA.
Prepare and lead weekly site meetings for multiple locations.
Communicate with other professionals via phone, email, and face-to-face meetings to ensure the whole clinical trial team is consistently aware of any relevant information and issues.
Ensure coordinators are ready and willing to conduct any study.