CLINICAL TRIALS SCREENING COORDINATOR II

Summary

Job Summary:

The Clinical Trials Screening Coordinator II serves as the primary liaison between the Clinical Trials Office and disease-specific programs, ensuring seamless integration of clinical trial opportunities into patient care pathways. This role is pivotal in identifying, screening, and enrolling eligible patients while collaborating with physicians, research teams, and caregivers to optimize trial access and compliance. The role performs an integrated approach to ensure effectiveness and efficiencies for directing potential patients to a trial program. The role has the primary responsibility for referring physicians, patients and caregivers to guide, review eligibility and provide access to available clinical trials.

The position assesses the needs of the various Principal Investigator’s (PI) clinical research protocols. The incumbent works under the supervision of the PI and CTO manager/supervisor and will improve or heavily influence the improvement of tracking and database systems, reporting, tools, processes and protocols, ensuring an integrated approach for effectiveness and efficiencies.

This is role is within the clinical trials career path supporting the PI in clinical trials. The supervisor or PI will provide more detailed instructions on new complex assignments where there is limited prior depth, or breadth of knowledge or working experience.

Supervision is moderately provided while developing latitude for independent judgment. The incumbent continues to develop and acquire higher level knowledge and skills, while working on moderate scope complexity where analysis of situations of data requires a review of a variety of factors. Solves a range of straight forward problems using prescribed guidelines and policies. Limited problem solving under defined guidelines. Continues to build productive internal/external working relationships.

Minimum Requirements

Bachelors Degree 4 (four) years' experience in clinical or clinical trials (patient facing coordination, screening and prescreening patients) data management, regulatory or other research coordination). This role is required to

have knowledge of the clinical research process, procedures, oncology and understanding of research protocols. Familiarity with clinic and office organization, procedures and protocols.

• For job qualification purposes, in lieu of 4 (four) years:
• 3 (three) years of clinical research experience and the Clinical Research Certification (CCRC/CCRP) certification obtained through SOCRA or ACRP is acceptable. Overall understanding of research project development and requirements. Demonstrated experience Microsoft software (Word, Excel, Power Point).
  
  

Clinical Trials Screening Coordinator II (CTSC II) is required to be highly proficient in word processing (Microsoft Office suite)

• Tracking of patient's enrollment through various tools, participate in patient screening dashboard development at the program level
• Through knowledge of Good Clinical Practice and the regulations necessary for the protection of human subjects and the conduct of clinical research.
• Should be proficient in the use of EMR systems, clinical trial management systems and other various data capture/reporting systems.
• Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals.
• Highly proficient understanding of medical terminology required. CTSC II is required to work under little guidance to plan, organize, and coordinate multiple work assignments, establish and maintain effective working relationships with others in a team setting, act as a subject matter expert and communicate clearly verbally and in writing.
• Must have ability to prioritize and pace one’s-self when working under the pressure of deadlines and work volume. Successfully demonstrates competency by meeting established competency guideline/check list annually.