Clinical Research Coordinator

Preferred Primary Care Physicians, Inc.•Pleasant Hills, PA

20d

About The Position

Preferred Primary Care Physicians is recruiting a full-time Clinical Research Coordinator to conduct pharmaceutical-sponsored clinical research trials. The role coordinates study activities at the site level across multiple studies and a variety of medical disciplines, including Type II Diabetes Mellitus, Cardiology, Gastrointestinal, Genitourinary, Headache, Respiratory, Virology, and Vaccine research. The coordinator handles regulatory documentation, recruitment and participant visits, study assessments, data entry, study supplies and investigational product or device accountability, and sponsor or IRB submissions. The role also includes training coordination, communication with patients and research partners, professional development, confidentiality and HIPAA compliance, and related clerical tasks.

Requirements

At least 2 years of experience in a health-related field (for example, RN, LPN, or MA), 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.
Clear communication skills.
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 across a variety of medical disciplines.
Maintain regulatory binders and organize study ancillary supplies.
Coordinate patient recruitment and complete patient visits and/or phone calls, carrying out required procedures and assessments.
Facilitate study monitoring visits and sponsor audits.
Manage required training and certifications for yourself and personnel listed on trial delegation-of-authority logs; training may cover study modules, electronic data-capture databases, drug dispensing, safety information, and laboratory collection.
Attend Investigator Meetings and/or training seminars as needed; travel may be involved.
Collect and assess subject adverse events and serious adverse events.
Administer and document the informed consent process and conduct and document general study visits.
Perform pulmonary function testing, 12-lead ECGs, phlebotomy, laboratory processing, packing and shipping, and vital-sign assessments.
Manage recruitment and enrollment for simultaneously enrolling studies and confirm eligibility against inclusion and exclusion criteria.
Enter data in EDC systems and resolve queries.
Maintain study drug and 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.
Interact professionally with patients, co-workers, office staff, and sponsor/CRO representatives.
Participate in educational and professional development activities, including weekly staff meetings and study qualification/initiation visits.
Follow HIPAA regulations and maintain strict confidentiality of medical and corporate information.
Perform related clerical duties, including answering calls, filing, organizing, and stocking rooms.