Clinical Research Coordinator II

Columbia University; New York (NY); In loco; USD 72.000 - 80.000; Tempo pieno

Descrizione del lavoro

The Eleanor and Lou Gehrig ALS Center at Columbia University Irving Medical Center in New York is seeking a Clinical Research Coordinator II to join the clinical research team. The CRC II will coordinate and conduct clinical trials for ALS, collaborating with physicians, sponsors, patients, and caregivers to advance novel therapies.

Collaboration with PIs and Research Managers will be essential to support a diverse portfolio of studies, with responsibilities spanning study coordination, data

Competenze

• Bachelor's Degree or equivalent in a relevant clinical research field.
• Strong critical thinking and analytical skills with the ability to interact with multiple stakeholders.
• Ability to work semi-independently in a deadline-driven, multi-tasking environment.
• Strong written and verbal communication skills.
• Commitment to fostering diversity and equity.
• Experience collaborating in a clinical research setting is beneficial.

Mansioni

• Responsible for day-to-day protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants.
• Effectively communicate and build relationships with study subjects, clinicians and research staff to support trial administration.
• Coordinates initiation and start-up of clinical trials with Research Managers, including protocol submissions, consent form modifications and budget approvals.
• Complete data entry with PHI and maintain accurate and complete trial files (CRFs, start-up/close-out docs).
• Record and report adverse event data per guidelines; liaise with PIs and care teams throughout the AE lifecycle.
• Prepare data reports and conduct periodic audits to ensure regulatory compliance and quality.

Conoscenze

Critical thinking

Analytical skills

Communication skills

Team collaboration

MS Excel

Formazione

Bachelor's Degree or equivalent in a relevant clinical research field

Strumenti

Epic

REDCap

Qualtrics

iLab

OpenSpecimen

Descrizione del lavoro

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range:72,350-80,350

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Eleanor and Lou Gehrig ALS Center is seeking a Clinical Research Coordinator II (CRC II) to join the clinical research team. The CRC II will play an integral role in coordinating and conducting clinical trials for amyotrophic lateral sclerosis (ALS), working closely with physicians, scientists, sponsors, patients, and caregivers to advance the development of novel therapies. Alongside the Principal Investigators and Research Managers, the CRC II will support a diverse portfolio of industry-sponsored, federally funded, foundation-supported, and investigator-initiated research studies.

Our staff is pivotal in facilitating and advancing these cutting-edge research endeavors.

Clinical Research Coordinators (CRCs) of every level are key members of research teams at Columbia. They collaborate closely with Principal Investigators (PIs) managing and overseeing the various aspects of clinical trials and research. Key responsibilities and tasks include study coordination, data collection, regulatory compliance, and serving as a Research liaison. The ideal candidate would need strong communication, organizational, and interpersonal skills.

To be successful in this role, the CRC II should bring strong critical thinking, organizational, and an ability to work collaboratively and independently in a deadline-driven environment.

Responsibilities

Clinical Trials Coordination

• Responsible for day-to-day aspects of study protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants, specimen processing and shipping, and other key elements (including ALS-specific outcome measures) under minimal supervision.
• Effectively communicate, build, and maintain relationships with potential study subjects, participants, clinicians, and other health care providers, and research office staff to support the successful administration of clinical trials.
• Coordinates initiation and start-up of clinical trials in collaboration with Research Managers, including protocol submission, consent form modifications, contract and budget execution, and approvals for ancillary service (e.g. Irving Clinical Research Center, research pharmacy, etc.).
• Complete data entry activities with little supervision. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data. Maintain accurate and complete clinical research files which include administering questionnaires, completing case report forms (CRFs), completing any study start-up or close-out documentation.
• Records and reports adverse event data according to institutional and sponsor guidelines; confers with PIs and Research Managers on reporting and maintains close contact with participants’ care teams throughout the adverse event lifecycle.
• Prepare data reports and perform periodic auditing of data, certification, and reporting materials to ensure regulatory compliance with university, sponsor and federal policies.
• Coordinate fiscal transactions related to the study including compensation to study subjects for their participation and helping them troubleshoot any issues.
• Adhere to workplace and patient safety protocols, monitor the area to ensure compliance with ethical and safety standards for research and maintain and request additional supplies as needed.
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.
• Performs all other duties as assigned.

Collaboration & Stakeholder Management

• Coordinate research team meetings, investigator check-ins, Sponsor visits, external audits and other stakeholder engagement activities.
• Demonstrates professionalism and accountability in interactions with clinical trials team and patients through clear, respectful, and timely communication and responsive follow-up.
• Supports training activities to ensure others understand clinical trial procedures.

Continuous Improvement

• Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers.
• Keeps current on all organizational policies, goals, and initiatives.
• Successfully completes all required university, systems, and department trainings and assigned study certifications requirements.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's Degree or equivalent in education, training, and experience in a relevant clinical research field.
• Must possess critical thinking and analytical skills, customer service orientation, with the ability to interact and collaborate positively, constructively and effectively with multiple stakeholders.
• Capacity to work semi-independently and successfully within a team in a deadline driven, multi-tasking environment. Ability to handle multiple projects and apply judgment to prioritize projects and tasks.
• Strong oral and written communication skills.
• Strong commitment to fostering diversity and equity.
• Skilled with Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.

Preferred Qualifications

• Bi-lingual (Spanish and English).
• 3 years’ experience in a clinical research setting.
• Prior experience in neurology, neurodegenerative disease research, or work with medically complex patient populations.
• Prior experience coordinating interventional clinical trials.
• Familiarity with Columbia health and research systems.
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpeciman.
• Understanding of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, Columbia IRB and other institutional or federal regulatory and compliance activities.
• Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nursing degree, medical degree) – current or willing to obtain within 3 months.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.