Directly reporting to the Lead Clinical Research Associate for designated area(s) of the Clinical Trials Department, under limited supervision, independently performs clinical research activities for a broad range of assigned non-therapeutic research studies in accordance with federal and state regulations, Institutional Review Board approvals and Connecticut Children’s policies and procedures. Additionally, supports Clinical Research Associates and Clinical Research Nurse Coordinators in the coordination and management of clinical trials. With increasing on-the-job experience, successful completion of competencies and mentorship, will assume responsibility for study coordination of clinical trials in addition to non-therapeutic studies. Works collaboratively with investigators, clinical research nurses, ancillary team members, and external parties (e.g. study Sponsors) to successfully execute trial specific protocol requirements.
STUDY COORDINATION AND MANAGEMENT (performs responsibilities under limited supervision):
Ensures compliance with study protocols and clearly and thoroughly documents each study participant visit.
Participates in recruitment and selection of clinical trial participants by reviewing medical history as well as protocol specified inclusion and exclusion criteria.
Participates in the consent/assent process ensuring the study participant and/or legal guardian understand all aspects of the study protocol including risks and benefits of participating in the clinical trial.
Provides timely information regarding each study visit to all ancillary departments as required e.g., Office for Grants and Sponsored
Programs, pharmacy, institutional review board, etc.).
Completes data collection as specified by the study protocol.
Provides timely information to study Sponsors including completion of data queries.
Oversees the procurement, preparation and shipping of research specimens as needed.
Meets with the Principal Investigator regularly during the trial to review progress, identify challenges and reconcile issues as necessary, documents meetings with investigators.
May transport study medication as needed from Connecticut Children’s research pharmacy to a Connecticut Children’s outpatient clinic in accordance with Connecticut Children’s Medication Transportation Policy.
STUDY START-UP/CLINICAL TRIAL INITIATION (performs responsibilities under limited supervision):
Participates in Connecticut Children’s internal study start-up process and works collaboratively with the study team to prepare study for activation.
May assist in the development of protocols, consents, and/or data collection methods.
Completes IRB submissions and organizes all regulatory and subject research records.
Establishes clear and consistent communication with the study Sponsor and all Connecticut Children’s team members involved in the study.
Attends clinical trial investigator meetings coordinated by the trial Sponsor.
RESEARCH COMPLIANCE (performs responsibilities under limited supervision):
Assists team members in performing quality assurance checks in accordance with department SOPs to ensure protocol compliance,
Good Clinical Practice (GCP) and all other applicable regulatory requirements.
Ensures all research records are compliant with study protocol requirements prior to monitor visits.
TRAINING AND EDUCATION:
Participates in all internal and external training sessions and meetings for assigned studies.
Participates in internal Clinical Trials team meetings and Connecticut Children’s research education sessions.
Maintains professional expertise through involvement in professional organizations and continuing education programs.
Demonstrates knowledge of the age-related differences and needs of patients in appropriate, specific populations from birth through young adults and applies them to practice.
Demonstrates cultural sensitivity in all interactions with trial participants and families.
Values cultural diversity and other individual…