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David Careers

Clinical Research Assistant 2; Full Time

Posted yesterday

connecticut childrensGlastonbury (CT)
Clinical Research CoordinatorsResearch and Development in the Physical, Engineering, and Life Sciences

SENIORITY

Mid

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About the role

Clinical Research Associate 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.
Responsibilities include:
  • Ensuring compliance with study protocols and thoroughly documenting each study participant visit.
  • Participating in recruitment and selection of clinical trial participants by reviewing medical history as well as protocol specified inclusion and exclusion criteria.
  • Participating 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.
  • Providing timely information regarding each study visit to all ancillary departments as required.
  • Completing data collection as specified by the study protocol.
  • Providing timely information to study Sponsors including completion of data queries.
  • Overseeing the procurement, preparation and shipping of research specimens as needed.
  • Meeting with the Principal Investigator regularly during the trial to review progress, identify challenges and reconcile issues as necessary, documenting 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 responsibilities include:
  • Participating in Connecticut Children's internal study start-up process and working collaboratively with the study team to prepare study for activation.
  • Assisting in the development of protocols, consents, and/or data collection methods.
  • Completing IRB submissions and organizing all regulatory and subject research records.
  • Establishing clear and consistent communication with the study Sponsor and all Connecticut Children's team members involved in the study.
  • Attending clinical trial investigator meetings coordinated by the trial Sponsor.
  • Research compliance responsibilities include:
  • Assisting 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.
  • Ensuring all research records are compliant with study protocol requirements prior to monitor visits.
  • Training and education responsibilities include:
  • Participating in all internal and external training sessions and meetings for assigned studies.
  • Participating in internal Clinical Trials team meetings and Connecticut Children's research education sessions.
  • Maintaining professional expertise through involvement in professional organizations and continuing education programs.
  • Demonstrating knowledge of the age-related differences and needs of patients in appropriate, specific populations from birth through young adults and applying them to practice.
  • Demonstrating cultural sensitivity in all interactions with trial participants and families.
  • Valuing cultural diversity and other individual differences in the workforce.
  • Demonstrating support for the mission, values, and goals of the organization through behaviors that are consistent with Connecticut Children's Medical Center standards.
  • Performing other related responsibilities as assigned.
  • Mentoring & educational responsibilities include:
  • Providing education regarding study specific protocol requirements to ancillary Connecticut Children's team members involved in the execution and conduct of the trial.
Qualifications include:
  • Education and/or Experience 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.
  • Position Specific Job License and/or Certification Required: Successful completion of the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects 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, Skills and Abilities Required:
  • Research protocols, research regulations, human research protection principles and Good Clinical Practice (GCP) guidelines.
  • An understanding of protocol elements, the ability to execute study procedures, and the ability to anticipate and mitigate potential protocol non-compliance.
  • 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.
  • An understanding of investigational product development process and applies key regulatory requirements to control these processes.
  • 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. Coordinate and manage communications with multiple internal and external stakeholders including clinical trial participant and family, ancillary team members, and study Sponsors. Problem solve, organize and adapt to changing priorities.

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