Sr Research Coordinator

About the Role

A Sr. Research Coordinator is involved in patient-related studies. This position will involve 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, data entry, and quality control of data.
• Revises, renews, and maintains IRB approval, protocols, and consent forms for studies.
• Submits clinical research projects to all applicable internal and external departments for required review and approvals.
• Reports status by generating a tracking mechanism to monitor the 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 preparing clinical research budgets that will render a financial return to the ID Research infrastructure.
• Educates all team members (physicians, nurses, pharmacists, research lab personnel) and assists in the performance of all research-related activities needed to conduct a clinical research trial.
• Assists in hypothesis generation, data collection, data analysis, and data presentation and publication.
• Assists investigators in writing research protocols specific to the ID Research Program.
• Interfaces with sponsors/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 a physician's or nurse practitioner's orders.

Qualifications

• 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 and maintain 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 with patients of all ages served by the assigned unit.
• Knowledge of the principles of growth and cognition over the life span and the ability to assess data reflective of the patient's status, interpret appropriate information, and identify each patient's requirements relative to their age-specific needs.

Licensure, Certifications, and Clearances

• Act 31 / Act 33 / Act 34 / Act 73 with renewal.