Job Abstract

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, various clinical support services, and external parties (e.g. study Sponsors) to successfully execute trial specific protocol requirements.

Job Duties

STUDY COORDINATION AND MANAGEMENT (performs responsibilities under limited supervision):
• Provides support for a minimum of three (3) divisions and/or three (3) investigators that includes two (2) complex clinical trials.
• 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.

Minimum education (degree/type of degree).
•Bachelor’s or Master’s degree in a health care related field; degrees in other areas may be substituted on a case-by-case basis.
Minimum experience (minimum years & type of experience)
• Bachelor’s degree with 2 years of clinical research experience or Master’s Degree with 1 year of clinical research experience.
Preferred education & experience
•Experience coordinating pediatric clinical trials

Required: SOCRA, ACRP or other research professional certification within one (1) year of eligibility; successful completion of the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects within 3 months of employment.

Knowledge of:
Demonstrates a fundamental knowledge of research protocols including each element of the protocol, investigational product development, clinical research participant safety and related documentation and reporting practices, research regulations, human research protection principals and Good Clinical Practice (GCP) guidelines.

Skilled at:
•With limited assistance, executing study procedures within scope of practice and providing coordination of clinical support services for study visits.
•Anticipating and mitigating potential protocol non-compliance and recognizes situations requiring prompt escalation, demonstrating actions to minimize risks.
•With limited assistance, coordinating and managing communications with multiple internal and external stakeholders including clinical trial participant and family, clinical support team members, and study Sponsors.
•Provide solutions for issues, organize and quickly pivot to adapt to changing priorities.
•Oral and written communication.
Ability to:
•To collect, verify and report study data via source documentation and apply ALCOA-C practices to the collection of data in a given study.
•To navigate a Windows environment including Outlook email, intermediate to advanced level word processing and spreadsheet skills (Microsoft Word & Excel); and intermediate to advanced skills developing presentations (Microsoft Powerpoint).
•To navigate multiple external Sponsor platforms including various electronic data collection (EDC) systems and e-regulatory platforms.
•To schedule appointments, document and track study visits and run reports within EPIC.