Directly reporting to the Lead Clinical Research Associate for a designated area(s) of the Clinical Trials Department, under limited supervision, coordinates and manages clinical trials in accordance with federal, and state regulations, Institutional Review Board approvals and Connecticut Children's policies and procedures. Under limited supervision, performs a full range of complex, clinical research activities for a broad range of assigned research projects. 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 clinical trial protocols and clearly and thoroughly documents each clinical trial 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 clinical trial participant and family understand all aspects of the study protocol including risks and benefits of participating in the clinical trial.

* Provides timely information regarding each clinical trial 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 clinical trial 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 clinical trial Sponsor and all Connecticut Children's team members involved in the trial.

* Attends clinical trial investigator meetings coordinated by the trial Sponsor.

STUDY COORDINATION AND MANAGEMENT (performs responsibilities under limited supervision):

* Ensures compliance with clinical trial protocols and clearly and thoroughly documents each clinical trial 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 clinical trial participant and family understand all aspects of the study protocol including risks and benefits of participating in the clinical trial.

* Provides timely information regarding each clinical trial 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 clinical trial 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 clinical trial Sponsor and all Connecticut Children's team members involved in the trial.

* 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 differences in the workforce.

* Demonstrates support for the mission, values, and goals of the organization through behaviors that are consistent with Connecticut Children's Medical Center standards.

* Performs other related responsibilities as assigned.

MENTORING & EDUCATIONAL RESPONSIBILITIES:

* Provides education regarding clinical trial specific protocol requirements to ancillary Connecticut Children's team members involved in the execution and conduct of the trial.

* Mentors Clinical Research Assistants/Interns including participation in the onboarding process.

Master's degree in a health care related field plus two (2) years of clinical research experience in a relevant discipline or Bachelor's Degree and four (4) years of relevant research experience. Degrees in other areas may be substituted on a case-by-case basis.

* Previous experience with assisting in the coordination of complex clinical trials.

Successful completion of the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects found at www.citiprogram.org within the first three months of employment.

* If not certified at time of hire, completion of certification exam for Clinical Research Professional given by the Association for Clinical Research Professionals ACRP or the Society of Clinical Research Associates SOCRA is required within three years of employment.

KNOWLEDGE OF:

Research protocols, research regulations, human research protection principles and Good Clinical Practice (GCP) guidelines.

SKILLS:

* Demonstrates an understanding of protocol elements, the ability to execute study procedures, and the ability to anticipate and mitigate potential protocol non-compliance.

* Demonstrates an understanding of the elements of clinical trial participant safety, related documentation and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.

* Demonstrates and understanding of investigational product development process and applies key regulatory requirements to control these processes.

* Demonstrates an understanding of procedures to prevent potential ethical and professional conflicts and how to manage such events should they occur.

* Demonstrated proficiency in Windows environment; intermediate to advanced level word processing and spreadsheet skills (Microsoft Word & Excel); and intermediate to advanced skills developing presentations (Microsoft Powerpoint); advanced skills in database design and database management (Microsoft Access)

* Excellent oral and written communication skills.

* Highly organized and adept at project management.

ABILITY TO:

* Ability to collect, verify and report study data via source documentation and apply ALCOA-C practices to the collection of data in a given study.

* Ability to coordinate and manage communications with multiple internal and external stakeholders including clinical trial participant and family, ancillary team members, and study Sponsors.

* Ability to problem solve, organize and adapt to changing priorities.