Advertised Summary Job Description: The Clinical Research Coordinator (CRC) will report to the Principal Investigator and Clinical Research Manager of federally and industry sponsored research at Columbia University within the Division of Maternal Fetal Medicine within the Department of Obstetrics and Gynecology. The candidate will play an integral role in the coordination and implementation of clinical trials involving human subject research. The CRC will be dealing with pregnant women's health in the ambulatory setting. He/she will report to the Principal Investigator and the Clinical Research Manager. The candidate will adhere to assigned clinical trial/research protocols and manual of operation set forth by the sponsor, maintain screening and randomization logs and handling of correspondence appropriately, will prepare and maintain research files and charts. Additionally, the candidate will consult with medical records of outlying clinics and hospitals to obtain pertinent data and patient information. The CRC may interface with various hospital departments such as medical records, radiology, nursing, information technology services, and others as needed.
The candidate will identify, recruit, and consent eligible participants; conduct visits as outlined in study protocols and in accordance with Good Clinical Practices (GCP) guidelines. The CRC will be responsible for collecting, transporting, processing and shipping blood samples in accordance with institutional policies and as delineated in sponsor's protocol. Additionally, CRC will be responsible for maintaining case report forms and data entry, and reporting of adverse events.
The incumbent will perform screening, counseling and recruitment of study subjects or identify potential patients for studies in research protocols. The coordinator will perform research-related services such as coordinating study visits, scheduling, telephone calls, data collection, data entry and transmission, specimen collection, processing and storing or shipment of specimens. Ensure the appropriate tests, procedures and laboratory tests are completed. The candidate will collect data and complete case report forms for all study visits as required by the protocol and consistent with GCP, FDA/HHS, state and institutional regulations. The CRC candidate will ensure regulatory documents and administrative files for each protocol are up to date. Patient research records will be created and maintained by the CRC. Position requires intercampus travel. The incumbent will also be required to enter research data into a centralized database program and other study specific electronic databases. Attend and participate in Investigator, site initiation and monitoring meetings as assigned. The candidate will perform other related duties as assigned.
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.
Additional Specific Minimum Qualifications: Prior experience working in a patient care setting for example a doctor's office, medical center, hospital or other. Excellent verbal and written communication skills and attention to detail required. Computer skills (Word, Excel) required. The candidate should be well-organized, a self-starter with excellent interpersonal skills and strong organizational qualities who can interact with patients, family members, physicians, and researchers.
Preferred Qualifications: Obstetrics and gynecology experience preferred. Fluency in Spanish (written and spoken)
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Internal Number: 126_174601
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.