Clinical Research Coordinator

The Schwarzman Animal Medical Center is looking for an experienced Clinical Research Coordinator (CRC) to join our hospital on the upper east side of Manhattan. Critical to the successful management of multiple ongoing clinical trials, the CRC acts to ensure productivity, regulatory compliance, study oversight, communication requirements with granting agency-related deadlines, relevant document fulfillment, communication with key collaborators, and timely completion of studies, and data audits. The CRC works closely with and under the guidance of the Principle Investigator and Chair, Research, and is responsible for supporting, facilitating, and coordinating daily clinical trial activities. The CRC will perform diverse administrative duties requiring patient/case accrual, coordinating data analysis, sound judgment, and a high level of knowledge of study specific protocols.

Essential Skills and Abilities

• High-level of critical thinking skills and innovative solutions
• Detail-oriented with an ability to process information quickly
• Strong interpersonal skills
• Conceptual knowledge of clinical research and drug development
• Experience working with IRBs and handling investigational product
• Adaptable and able to function well under pressure
• Understanding of protocol design, informed consent, clinical trial design, study advertising, IRB communication, and subject randomization highly preferred
• Phone experience and telephone recruitment skills
• Demonstrated strengths in planning, organizational, project management and analytical skills
• Advanced computer skills (word processing, electronic data collection and entry, graphics, presentation slides)

Responsibilities (including, but not limited to, the following):

I. General Administrative

• Coordinates with PI and Chair, research to ensure that clinical research and related activities are performed in accordance with federal regulations and all appropriate policies and procedures.
• Assists in the development of materials and tools necessary to properly train individuals involved in the conduct of the study around issues related to protocol requirements, schedule of visits, and execution of research plan.
• Assists in assuring that all team members ‘engaged’ in the study have met appropriate training requirements.
• Cooperates with compliance and monitoring efforts and helps to coordinate and facilitate monitoring and auditing visits.
• Assists with study feasibility assessments as requested.

II. Protocol Preparation & Review

• Thoroughly reviews and comprehends the protocol.
• Prepares IRB IACUC and any other regulatory submission documents as required by the protocol.
• Prepares other study materials as requested by PI, including, but not limited to, informed consent document, pre-screen/enrollment logs, temperature logs, and drug/device accountability logs.
• Establishes and organizes study files, including regulatory binders, study specific source documentation, and other materials.

III. Conduct of Research

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists in communication of study requirements to all individuals involved in the study.
• Collects documents needed to initiate the study and submit to the sponsor.
• Helps to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the IRB IACUC and discussions with research participants, including answering any questions related to the study.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Coordinates and schedules participant tests and procedures.
• Collects and records data as required by the protocol, assuring timely completion of all necessary documents.
• Completes study documentation and maintains study files in accordance with requirements.
• Retains all study records in accordance with sponsor requirements.
• Maintains effective and ongoing communication with sponsor, research participants and research team during the course of the study.
• Helps to manage the day to day activities of the study including problem solving, communication and protocol management.

IV. Reporting

• Assists PI with scientific and compliance reporting requirements in accordance with federal regulations and/or research protocol.

V. Project Closeout

• Assists in the submission of accurate and timely closeout documents including sponsoring agency (Pharma), granting agencies, collaborating institutions, or other study-related parties.
• Maintains secure storage of study documents.
• Coordinates post hoc audit with PI and communicates with Research Chair

Qualifications

Related medical or veterinary healthcare degree, masters preferred.
Minimum 4 years medical research experience.

Job Type

Full-time or part-time

Benefits Package Includes

• Competitive salary
• Generous paid time off
• 50% discount on veterinary care
• Continuing education funds with rollover options
• 403(b) matching
• Comprehensive medical, dental, and vision coverage
• You may be eligible for The Public Loan Service Forgiveness Program as we are a 501(c)(3) nonprofit employer