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1 Vacancy
Location:
Lippincott 303 Lippincott DriveEmployment Type:
EmployeeEmployment Classification:
Per DiemTime Type:
Part timeWork Shift:
1st Shift (United States of America)Total Weekly Hours:
0Additional Locations:
100 RemoteJob Information:
Job Summary:
Coordinates and participates in clinical research studies conducted by principal investigators. Acts as a liaison for clinical investigators and IRB Coordinators to ensure compliance of general and study specific regulatory processes for reporting to various regulatory agencies.
Position Responsibilities
Conducts complete timely data management activities as required by protocol which may include quality improvement data and tracking information submitted to clinical trial sponsors and regulatory agencies.
Coordinates visits for pharmaceutical and cooperative group trials. Provides information to Principal Investigators for patients and families regarding research trials participation and assists physicians & patients with informed consent process. Responsible for submitting all documentation and specimens to sponsoring organizations in compliance with protocol specifications.
Liaise with Regulatory Agencies (IRB NCI and FDA) for project compliance.
Participates in meetings to facilitate research projects (IRB meetings Research Review Committee meetings etc.. Ensures appropriate studies are available at Virtua and educate staff of regulatory changes or updates.
Position Qualifications Required:
Required Experience: 25 years data management clinical research experience and strong administrative experience. Strong organizational skills required. Excellent communication and interpersonal skills required to communicate with patients families physicians and nurses.
Required Education: HS graduate; Associate/bachelors degree preferred.
Training /Certification /Licensure: National Institute of Health Human Subjects Protection Certification; CCRP or CCRC certification preferred. Willingness to be trained to perform phlebotomy if needed.
Required Experience:
IC
Part-Time