Clinical Research Coordinator

Preferred Primary Care Physicians, Inc; Pittsburgh (Allegheny County); Presencial; USD 42.000 - 64.000; Jornada completa

Descripción de la vacante

Preferred Primary Care Physicians, Inc is currently recruiting a full-time Clinical Research Coordinator to oversee pharmaceutical sponsored trials across diverse disciplines. The role covers regulatory maintenance, patient recruitment, visits, data entry, and study documentation while ensuring HIPAA compliance.

Candidate should have at least 2 years in a health-related field and be able to coordinate multiple responsibilities, communicate clearly, and work independently with minimal

Formación

• At least 2 years of experience in a health-related field (e.g., RN, LPN, MA) or equivalent combination of education and experience.

Responsabilidades

• Coordinate all aspects of study procedures at-site for industry-sponsored trials across multiple disciplines.
• Maintain regulatory binders and organize study supplies; recruit patients and complete visits and calls.
• Complete trainings and certifications; may travel for Investigator Meetings and trainings.
• Perform study procedures such as adverse event collection, ICF administration, pulmonary function testing, ECG, phlebotomy, lab processing, vital signs, and drug accountability.
• Manage enrollment and eligibility, conduct EDC entry and sponsor/IRB document submissions.
• Interact professionally with patients, staff, and sponsor/CRO representatives.
• Participate in meetings and development activities; maintain HIPAA confidentiality.
• Handle clerical duties related to the position.

Conocimientos

Relationship building

Calm under pressure

Clear communication

Reading and following instructions

Multitasking / self-motivation

Descripción del empleo

Preferred Primary Care Physicians is currently recruiting for a full-time Clinical Research Coordinator.

General Purpose of the Position:

This role will require the applicant to attend to all aspects and responsibilities involved in conducting Pharmaceutical sponsored clinical research trials.

Essential Duties and Responsibilities:

• Coordinate all aspects of study procedures at the site level for multiple industry sponsored studies in a wide variety of disciplines, such as Type II Diabetes Mellitus, Cardiology, Gastrointestinal, Genitourinary, Headache, Respiratory, Virology and Vaccine.
• Maintain regulatory binders, keep study ancillary supplies organized and accessible, coordinate patient recruitment, complete patient visits and/or phone calls by executing all patient procedures/assessments, and facilitate study monitoring visits and/or sponsor audits.
• Manage necessary trainings and certifications for yourself and those listed on the delegation of authority logs for your assigned trials. Trainings include but are not limited to study specific training modules, various electronic databases for data capture, drug dispensing, safety information, and lab collection. Travel may be involved for attending Investigator Meetings and/or other training seminars.
• Execute the following study procedures/assessments with proficiency: 1. collect/assess subject Adverse Events and/or Serious Adverse Events, 2. administer and document ICF process, as well conducting and documenting general study visits, 3. perform pulmonary function testing, 12-lead ECG, phlebotomy, lab processing/packing/shipping, and vital signs, 4. manage subject enrollment/recruitment for simultaneously enrolling studies, assuring eligibility according to inclusion/exclusion criteria, 5. EDC entry and query resolution, 6. maintain study drug/device accountability/storage, dispensing/collecting and subject compliance, 7. submit/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 as necessary, such as weekly staff meetings, study qualification/initiation visits, etc.
• Follow all HIPAA regulations, and maintain the strictest confidentiality of medical/corporate information.
• Other responsibilities include clerical work such as answering telephone calls, filing, organizing, stocking rooms, etc. as it relates to your position.

Education/Experience:

At least 2 years of experience in a health-related field (e.g., RN, LPN, MA), clinical research, or equivalent combination of education and experience.

Skills/Competencies:

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 multi-task.