Clinical Research Assistant 2; Full Time

Connecticut Children's Medical Center•Hartford, CT

12d

About The Position

Directly reporting to the Lead Clinical Research Associate for designated areas of the Clinical Trials Department, the Clinical Research Assistant 2 independently performs clinical research activities for a broad range of assigned non-therapeutic research studies under limited supervision. Work must comply with federal and state regulations, Institutional Review Board approvals, and Connecticut Children’s policies and procedures. The role also supports Clinical Research Associates and Clinical Research Nurse Coordinators in coordinating and managing clinical trials. With additional experience, successful competency completion, and mentorship, the assistant may assume responsibility for coordinating clinical trials as well as 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 trial-specific protocol requirements. Responsibilities include study coordination and management, study start-up, research compliance, training and education, and providing protocol-specific education to ancillary team members. The role requires sensitivity to the age-related needs of patients from birth through young adulthood and cultural diversity among participants, families, and colleagues.

Requirements

Bachelor’s degree in a health care related field; a degree in another area may be substituted on a case-by-case basis.
At least 1 year of prior clinical research experience or health care related experience in a professional, internship, or volunteer role.
Complete the CITI Course in the Protection of Human Research Subjects within the first three months of employment.
Complete the ACRP or SOCRA Clinical Research Professional certification exam within three years of employment.
Acquire knowledge of research protocols, research regulations, human research protection principles, and Good Clinical Practice guidelines within the first three months of employment.
Within the first three months, demonstrate understanding of protocol elements, execution of study procedures, and anticipation and mitigation of potential protocol non-compliance.
Within the first three months, demonstrate understanding of clinical trial participant safety, associated documentation and reporting, and situations requiring prompt escalation and risk mitigation.
Within the first three months, demonstrate understanding of investigational product development and relevant regulatory controls.
Within the first three months, demonstrate understanding of procedures for preventing and managing potential ethical and professional conflicts.
Demonstrate proficiency in a Windows environment; intermediate to advanced word processing and spreadsheet skills using Microsoft Word and Excel; intermediate to advanced presentation development skills using Microsoft PowerPoint; and advanced database design and management skills using Microsoft Access.
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 and manage communications with multiple internal and external stakeholders, including participants and families, ancillary team members, and Sponsors.
Demonstrate problem-solving, organizational, and adaptability skills in response to changing priorities.

Responsibilities

Ensure compliance with study protocols and thoroughly document each study participant visit.
Participate in recruitment and selection of 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 the study protocol, risks, and benefits.
Provide timely study-visit information to ancillary departments, including 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 shipment 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 when needed from the research pharmacy to an outpatient clinic in accordance with Connecticut Children’s Medication Transportation Policy.
Participate in internal study start-up and collaborate with the study team to prepare studies for activation.
Assist with development of protocols, consents, and data collection methods when needed.
Complete IRB submissions and organize regulatory and subject research records.
Establish clear communication with study Sponsors and Connecticut Children’s team members involved in the study.
Attend clinical trial investigator meetings coordinated by the Sponsor.
Assist team members with quality assurance checks under department SOPs to ensure protocol compliance, Good Clinical Practice, and other 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 programs.
Apply knowledge of age-related differences and needs among patient populations from birth through young adulthood.
Demonstrate cultural sensitivity in interactions with trial 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.
Perform other related responsibilities as assigned.
Educate ancillary Connecticut Children’s team members about study-specific protocol requirements.
Complete the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects within the first three months of employment.
Complete a Clinical Research Professional certification exam through ACRP or SOCRA within three years of employment.