Clinical Research Assistant 2; Full Time

Connecticut Children's•Hartford, CT

12d

About The Position

The Clinical Research Assistant 2 reports directly to the Lead Clinical Research Associate for designated areas of the Clinical Trials Department. Under limited supervision, the role 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. The assistant also supports Clinical Research Associates and Clinical Research Nurse Coordinators in coordinating and managing clinical trials. With increasing experience, successful completion of competencies, and mentorship, the role will take on clinical trial study coordination in addition to non-therapeutic studies. The position works collaboratively with investigators, clinical research nurses, ancillary team members, and external parties such as study Sponsors to carry out protocol requirements. The role coordinates and manages studies, supports clinical trial start-up and initiation, assists with research compliance and quality assurance, and participates in study-related and professional training. It also provides education to ancillary team members about study-specific protocol requirements. The position serves pediatric research populations from birth through young adulthood and is expected to demonstrate cultural sensitivity and support Connecticut Children’s mission, values, and goals.

Requirements

Bachelor’s degree in a health care-related field; degrees in other areas may be substituted on a case-by-case basis.
At least 1 year of previous clinical research experience or health care-related experience in a professional, internship, or volunteer role.
Complete the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects within the first three months of employment.
Complete the Clinical Research Professional certification exam from ACRP or SOCRA within three years of employment.
Acquire knowledge within the first three months of research protocols, research regulations, human research protection principles, and Good Clinical Practice guidelines.
Within the first three months, demonstrate understanding of protocol elements and study procedures, and the ability to anticipate and mitigate potential protocol non-compliance.
Within the first three months, demonstrate understanding of clinical trial participant safety, related documentation and reporting, and situations requiring prompt escalation and risk-minimizing action.
Within the first three months, demonstrate understanding of investigational product development and applicable regulatory requirements.
Within the first three months, demonstrate understanding of how to prevent and manage potential ethical and professional conflicts.
Demonstrate proficiency in the Windows environment, intermediate-to-advanced word processing and spreadsheet skills using Microsoft Word and Excel, and intermediate-to-advanced presentation development skills using Microsoft PowerPoint.
Demonstrate advanced skills in Microsoft Access database design and management.
Have excellent oral and written communication skills.
Be highly organized and adept at project management.
Within the first three months, demonstrate the ability to collect, verify, and report study data through source documentation and apply ALCOA-C practices.
Within the first three months, demonstrate the ability to coordinate communications with multiple internal and external stakeholders, including participants and families, ancillary team members, and Sponsors.
Within the first three months, demonstrate problem-solving skills and the ability to organize and adapt to changing priorities.

Responsibilities

Ensure compliance with study protocols and thoroughly document each study participant visit.
Participate in recruiting and selecting clinical trial participants by reviewing medical histories and protocol inclusion and exclusion criteria.
Participate in the consent and assent process, ensuring participants and/or legal guardians understand study protocols, risks, and benefits.
Provide timely study-visit information to ancillary departments and other relevant parties, including the Office for Grants and Sponsored Programs, pharmacy, and the Institutional Review Board.
Collect data as specified by study protocols and provide timely information to Sponsors, including responses to data queries.
Oversee procurement, preparation, and shipping of research specimens as needed.
Meet regularly with the Principal Investigator to review trial progress, identify challenges, and reconcile issues; document investigator meetings.
Transport study medication from the research pharmacy to an outpatient clinic when needed and in accordance with Connecticut Children’s policy.
Participate in internal study start-up and collaborate with study teams to prepare studies for activation.
Assist in developing protocols, consent documents, and/or data collection methods as needed.
Complete IRB submissions and organize regulatory and participant research records.
Establish clear and consistent communication with study Sponsors and Connecticut Children’s team members involved in each study.
Attend clinical trial investigator meetings coordinated by the Sponsor.
Assist team members with quality assurance checks under department SOPs to support protocol compliance, Good Clinical Practice, and applicable regulatory requirements.
Ensure research records meet study protocol requirements before monitor visits.
Participate in internal and external training sessions and meetings for assigned studies, Clinical Trials team meetings, and research education sessions.
Maintain professional expertise through professional organizations and continuing education.
Apply knowledge of age-related differences and needs among patients from birth through young adulthood.
Demonstrate cultural sensitivity in interactions with participants and families and value diversity and individual differences in the workforce.
Support the organization’s mission, values, and goals through behavior consistent with Connecticut Children’s Medical Center standards.
Provide ancillary team members with education about study-specific protocol requirements.
Perform other related responsibilities as assigned.