Summary: The CRS will act as a liaison between the QCCA network research sites and ConcertAI and its Digital Trial Solution (DTS) team. The role of the Clinical Research Specialist (CRS) is to implement digital research tools within Digital Trials Solutions (DTS) and coordinate deployment to the QCCA membership practices. The CRS will be trained in the use of digital tools that will assist with enhancing study start-up, supporting subject selection and enrollment, data entry and completion from EMR to EDC, and management of data processes. The CRS must have thorough knowledge of the research process and the conduct of studies under Good Clinical Practice/ICH Guidelines. This position will play a critical role in determining study feasibility for the network, initial prescreening of patients, and identifying patients with rare genetic mutation matches for clinical trials.
Essential Duties and Responsibilities include the following.
- Be trained in, and master the use of, digital clinical trials tools designed to manage clinical trials and apply them to the DTS-enabled studies.
- Work closely with DTS services team to advance the functionality and DTS user experience as well as ensuring protocol compliance with study execution.
- Work closely with the network study sites to create and maintain a workflow for data completion and act as a liaison between the study sites and DTS.
- Assist sites with subject screening within DTS.
- Assure timely completion of all Case Report Forms and other trial documents.
- Comply with documentation requirements and data completion guidelines from sponsor companies.
- Manage the digital implementation of the DTS eCRFs (electronic Case Report Forms): Initiate downloading of EMR data and uploading of appropriate EMR study data into DTS platform for eCRF completion of structured and unstructured data; Review and verify completed eCRFs and submission of eCRFs to the Sponsor EDC (Electronic Data Capture).
- Attend trial Start-up meetings for assigned trials.
- Foster collaborative working relationships with co-workers, research and practice staff.
- Abide by the Code of Federal Regulations referring to GCP and ICH guidelines per protocol.
- Participate as necessary in site audits by Sponsors, FDA, or other entities.
- Assist with Standard Operating Procedure development initially and during program growth.
- Maintains strictest confidentiality; adhere to all HIPAA guidelines/ regulations.
- Attends meetings and /or training as required
- Use problem-solving and conflict resolution skills to foster effective work relationships with team members.
- Maintain required competencies for self and all employees within the department.
- Pursue professional growth and participates in a professional organization.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Demonstrated knowledge of the clinical research process including a working knowledge of all functional areas of clinical trials.
- Have experience and knowledge of remote data entry and demonstrate ease and flexibility in learning and adopting computer programs and digital tools.
- Organized, meticulous, detail-oriented.
- Possess excellent communication skills and the ability to train site staff on new data tools and complex computer modules.
- Ability to manage several priorities within multiple trials.
- Ability to maintain professional attitude.
- Flexibility to work both independently and remotely.
- 3 to 5 years of clinical experience and 2 to 4 years of clinical research experience.
- Bachelors or Masters Degree in a healthcare field, preferably a nursing degree.
- Oncology background required.