Clinical Research Coordinator

The position will report directly to the study Principal Investigator at Columbia or his/her designee.

At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. We apply the same rigor in our commitment to fostering an inclusive, thriving community and caring for our employees and their loved ones. We offer immediate eligibility and invest in our employees' families through comprehensive Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

STUDY COORDINATION AND MANAGEMENT:

• Participate in recruitment and selection of potential study participants by reviewing medical history as well as protocol specified inclusion and exclusion criteria and discusses with PI.
• Participate 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.
• Document and provide timely and consistent communication regarding each clinical trial visit to key personnel including the Data Coordinating Center at Connecticut Children's Hospital.
• Communicate with study participants by sending study correspondence via mail or email.
• Perform simple study procedures with accuracy.
• Completes data and specimen (e.g., blood, stool, tissue) collection as specified by the research protocol/s.
• Oversee the procurement, preparation and shipping of research specimens as needed.
• Reconcile issues as necessary; document meetings with investigators.
• Process subject reimbursement using pcards or TruCentive.
• Retrieve and utilize information from electronic medical records (Epic) and databases/CTMS/EDC.
• Maintain essential regulatory documents as required.
• Maintain collegial relationships with colleagues in other studies and assist to the extent possible and approved by PI.
• Cross Coverage for other studies.

DATA COORDINATION:

• Collect basic demographic information during study visits.
• Enter data into forms (CRFs) on paper, databases, or electronic data capture systems (EDCs).
• Administer minimal risk consents independently (or complex consents under supervision).
• Verify the accuracy of own work and resolve simple queries.
• Build and maintain patient research study charts.
• Assist in quality control efforts, such as reviewing consents for signatures.

STUDY START-UP/CLINICAL TRIAL INITIATION:

• Participate in start-up process and work collaboratively with the study team to prepare potential ancillary studies for activation.
• May assist in the development of ancillary protocols, consents, and/or data collection methods.
• Oversee IRB communications and all regulatory and subject research records.
• Attend clinical trial investigator meetings coordinated by the trial Sponsor.

ADMINISTRATIVE:

• Assist in scheduling subjects for relevant research visits and follow-up appointments.
• Monitor study calendar for completion of study procedures.
• Manage study supply inventory.
• Utilize documents and systems to track recruitment and retention of participants.
• Maintain regulatory documents in appropriate binder
• Performs related duties & responsibilities as assigned/requested.

RESEARCH COMPLIANCE & REGULATORY COORDINATION:

• Lead quality assurance checks in accordance with department SOPs to ensure CAMEO protocol compliance, Good Clinical Practice (GCP) and all other applicable regulatory requirements.
• Ensure all research records are compliant with study protocol requirements prior to monitor visits.
• Immediately notifies PI of pending internal or external regulatory communications or audits.
• Collaborate with regulatory support to collect essential documents and maintain the regulatory binder (e.g., CVs, MD licenses, lab certifications, IRB rosters, lab norms).
• Assist with adverse events (AEs) and serious adverse events (SAEs).
• Follow proper documentation techniques as outlined in the International Council for Harmonisation – Good Clinical Practice (ICH-GCP) guidelines.

TRAINING AND EDUCATION:

Provides education regarding clinical trial specific protocol requirements to ancillary staff as directed by PI.

• Participate in all internal and external training sessions and meetings for CAMEO.
• Participate in internal Clinical Research team meetings.
• Maintain professional expertise through involvement in relevant education programs.
• Demonstrate knowledge of the age-related differences and needs of patients in CAMEO study population.
• Demonstrate cultural sensitivity in all interactions with trial participants and families.
• Value cultural diversity and other individual differences in the workforce; demonstrate support for the mission, values, and goals of the organization through behaviors that are consistent with Columbia Standards.
• Performs other related responsibilities as assigned.

Minimum Qualifications

Bachelor's degree or equivalent in education and experience required.

Preferred Qualifications

• Two years of related experience.
• Bilingual.

Other Requirements

• Excellent organizational skills.
• Ability to communicate well.
• Ability to operate independently.
• Works well within a team environment but also able to work independently.