Title: Site Lead
Position: Full-Time, Salaried
Based at: TCR - Spartanburg
Position Summary: This position will serve as a Site Lead for the Tribe Clinical Research Coordinators in Spartanburg. The Site Lead will assist with the oversight of clinical trials conducted at the Spartanburg Tribe Clinical Research office, 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.
Key Skills and Competencies:
- Currently a licensed CRC (RN/LPN) or CCMA or willingness to complete
- Medical and Clinical Research Terminologies
- Excellent verbal, written & 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
Primary Accountabilities:
- Lead, Manage, Accountable - oversee workload, onboarding.
- Oversee site processes to follow TCR standards.
- Perform Clinical Research Coordinator responsibilities.
- Respectful communication with Team, Investigators and Sponsors.
- Input on study team assignments making sure team goals are clear and tasks delegated appropriately.
- Navigate operations/site issues.
General Accountabilities:
- Trains, directs, and manages other clinical trial associates making sure all individuals are up to date on all aspects of a clinical trial.
- Oversee/Manage coordinator workload and give input on study assignments at multiple locations.
- Oversee organization and workflow of trials with meticulous attention to detail and ordering of priorities.
- Assist coordinators with sponsor/study issues.
- Oversee Maintenance of organized, complete study charts, and legible, accurate research documentation through written progress notes.
- Ability to complete in-depth documentation through written progress notes.
- Oversee communication with sponsor/study issues.
- Oversee day-to-day operations of site operations as pertains to study schedules.
- Oversee clinical responsibilities, such as blood draws, processing, vaccine administration.
- 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.
- 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 TCR Research Team of problems limiting recruitment and work on strategies to overcome these problems.
- Supervise maintenance of detailed drug accountability.
- Oversee 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 mandated timeframe.
- Maintains 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 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.
- Responsible for ensuring coordinators are ready and willing to conduct any study.
This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description and other duties, as assigned, might be part of the job.
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. This position may require travel, lifting (up to 50 pounds), sitting, standing, and walking associated with a normal clinical research / physician office environment. A person in this position may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens.
This position requires adherence to Tribe Clinical Research’s Core Values as outlined:
- We are passionate about working for a GROWTH ORIENTED company.
- We exhibit a HUMBLE but CONFIDENT approach to work.
- We communicate what needs to be said RESPECTFULLY.
- We love serving others and WORKING TOGETHER for the greater good.
- We can take constructive feedback well and have a POSITVE ATTITUDE even when the going gets tough.
Reporting Structure: Director of Operations
Tribe Clinical Research is an Equal Opportunity Employer
