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Connecticut Children's · 4 days ago

Clinical Research Assistant 2-Hem/Onc

10 Columbus Blvd, Hartford, CT, 06106, US

Full-time

Onsite

Entry Level

1+ years exp

Connecticut Children's is the only health system in Connecticut dedicated entirely to children. They are seeking a Clinical Research Assistant to perform clinical research activities for non-therapeutic studies, support clinical trial coordination, and ensure compliance with study protocols.

Health CareHospitalMedical

Responsibilities

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

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

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

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

Provides education regarding study specific protocol requirements to ancillary Connecticut Children’s team members involved in the execution and conduct of the trial

Qualification

Clinical research experienceClinical Practice (GCP)Human research protectionMicrosoft ExcelMicrosoft WordProject managementCultural sensitivityOral communicationWritten communicationOrganizational skills

Required

Bachelor's degree in a health care related field. Degrees in other areas may be substituted on a case-by-case basis

A minimum of 1 year previous clinical research experience or health care related experience in a professional, internship or volunteer role

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

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

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 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

Company

Connecticut Children's

Connecticut Children’s is a leading pediatric academic medical center consistently ranked by our peers as among the best children’s hospitals in the nation.

Founded in 1996

Hartford, Connecticut, USA

1001-5000 employees