Clinical Research Coordinator

Preferred Primary Care Physicians•Pittsburgh, PA

10d

About The Position

Preferred Primary Care Physicians is recruiting a full-time Clinical Research Coordinator to conduct pharmaceutical-sponsored clinical research trials. The coordinator manages site-level study procedures for multiple industry-sponsored studies across disciplines including Type II Diabetes Mellitus, Cardiology, Gastrointestinal, Genitourinary, Headache, Respiratory, Virology, and Vaccine research. The position includes patient-facing study activities, regulatory and data-management responsibilities, maintaining study supplies and drug or device accountability, and supporting monitoring visits and sponsor audits. Travel may be required to attend Investigator Meetings or training seminars. The coordinator also manages training and certifications for themselves and personnel listed on delegation of authority logs for assigned trials. They interact professionally with patients, colleagues, office staff, and sponsor or CRO representatives; participate in staff meetings and professional development; follow HIPAA requirements and protect confidential information; and perform related clerical tasks.

Requirements

At least 2 years of experience in a health-related field, clinical research, or an equivalent combination of education and experience.
Ability to establish and maintain effective working relationships.
Ability to react calmly in emergency situations.
Ability to communicate clearly.
Ability to read, understand, and respond to detailed written and oral instructions.
Ability to be self-motivated, work independently, and multitask.

Responsibilities

Coordinate site-level procedures for multiple industry-sponsored studies.
Maintain regulatory binders and keep study ancillary supplies organized and accessible.
Coordinate patient recruitment and manage enrollment for simultaneously enrolling studies, confirming eligibility against inclusion and exclusion criteria.
Complete patient visits and phone calls and conduct and document study procedures and assessments.
Collect and assess subject adverse events and serious adverse events.
Administer and document the informed consent process and general study visits.
Perform pulmonary function testing, 12-lead ECGs, phlebotomy, laboratory processing, packing and shipping, and vital-sign measurements.
Enter data in electronic data capture systems and resolve queries.
Maintain study drug or device accountability and storage, dispense and collect study products, and monitor subject compliance.
Submit and maintain sponsor and/or IRB documents for each study protocol.
Facilitate study monitoring visits and sponsor audits.
Manage required training and certifications for themselves and personnel listed on delegation of authority logs.
Interact professionally with patients, coworkers, office staff, and sponsor or CRO representatives.
Participate in educational and professional development activities, including weekly staff meetings and study qualification or initiation visits.
Follow HIPAA regulations and maintain strict confidentiality of medical and corporate information.
Perform related clerical duties, including answering telephone calls, filing, organizing, and stocking rooms.