Sr Research Coordinator

About the role

A Sr. Research Coordinator is involved in patient-related studies, including contact with study participants, scheduling appointments, administering research questionnaires, follow-up of study participants, collecting, entering and verifying data, assisting in quality control procedures and general clinical research assistance.

Responsibilities

• Supervises and directs the research staff team, inclusive of the data specialist, students and temporary employees.
• Collects information, data and source documents appropriate to study protocols.
• Transcribes information from source documents to case report forms.
• Maintains and updates computerized databases and records related to research participants, experimental data and related materials.
• Maintains confidentiality and security of records.
• Follows mandatory reporting procedures for any incident or serious event that did affect or potentially could have affected the clinical care of any patient.
• Completes online IRB certification modules 1 and 2 (Research Practice Fundamentals) in accordance with Health Sciences at the University of Pittsburgh.
• Follows appropriate research policies and procedures including all applicable laws and regulations and maintains scientific integrity including accurate data storage.
• Performs duties for approved research projects according to defined protocols and procedures including appropriate collection, recording, and storage of data.
• Administers questionnaires and assists with procedures for obtaining patient screening and recruitment as well as obtaining research specimens.
• Assists in data collection and data entry and quality control of data.
• Revises, renews and maintains IRB approval, protocols and consent forms for studies.
• Submits the clinical research projects to all applicable internal and external departments for required review and approvals.
• Reports status by generating a tracking mechanism to monitor activity of all ID Research trials.
• Maintains a safe, clean laboratory-working environment including appropriate equipment maintenance and usage, by conforming to laboratory and hospital policies and standards.
• Maintains laboratory inventory, including timely ordering and receipt of required supplies and their proper storage.
• Selects, examines and prepares gross and/or segmental anatomical specimens for exhibiting and laboratory work.
• Processes, labels, stores and ships blood specimens obtained from research subjects, maintaining IATA certification.
• Assists the Program Director in preparation of the clinical research budgets which will render a financial return to the ID Research infrastructure.
• Assists in hypothesis generation, data collection, data analysis and data presentation and publication.
• Assists the investigators in the writing of research protocols specific to the ID Research Program.
• Interfaces with the sponsor/investigators regarding the future influx of research projects to ensure a continued flow of clinical trials.
• Takes medical histories, administers blood pressure screenings, draws blood samples, and dispenses research medications under physician's or nurse practitioner's orders.

Requirements

• BA Degree required.
• 3-5 years of experience in coordinating multiple aspects of research projects (patient recruitment, assessment, treatment planning, and data collection, budgeting) required.
• 1 year of supervisory experience.
• Phlebotomy skills a plus.
• Computer Skills (Microsoft Office Products).
• IRB experience preferred.
• Ability to accurately collect, and store research data.
• Excellent communication skills both verbal and written.
• Demonstrated ability to effectively communicate with patients, staff and investigators as well as maintain patient confidentiality.
• Strong organizational skills.
• Ability to work independently, must be able to work a flexible schedule based on study needs.
• Ability to interact with patients/study participants and research and medical staff.
• Knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by his/her assigned unit.

Qualifications

Licensure, Certifications, and Clearances: Act 31 / Act 33 / Act 34 / Act 73 with renewal.