Hospital, Public and Private, Independent Medical Groups, Research Facility
Come contribute your talents and expertise helping develop and support the infrastructure for ethically sound research practices!
Provision Research Compliance offers training, consulting services and technologies to support regulatory compliance, helping support clinical research programs and protect study participants. Provision is a division of Schulman IRB’s consulting arm. Our experts work collaboratively with clients, helping them to strengthen and grow their research enterprises. Services are provided for academic research institutions, hospital systems and contract research organizations (CROs), and industry sponsors.
We are seeking to engage with motivated industry professionals to be prepared for future projects.
Projects will cover a broad range of areas related to human research protection and will tap into your expertise including but not limited to: drug and device studies and regulations, IRB Education & Training, SOP development and assessment, bio-banking, investigator training, data privacy, and medical writing.
Consulting experience required
Minimum 10 years’ applied experience in regulatory affairs governing Human Subject Protection, preferably in clinical research/conduct of clinical trials
Previous experience either on an IRB or in the management of an Human Research Protection Program
Comprehensive knowledge, understanding & experience in the application of Human Subject Protection, regulations and guidances, including FDA, OHRP, Health Canada & ICH
Certified IRB Professional (CIP status) preferred
Membership in research related professional organizations (i.e., PRIM&R; ACRP)
Knowledge of AAHRPP accreditation standards
Demonstrated ability to develop and facilitate adult education curricula
Strong interpersonal skills and ability to work effectively with diverse constituencies
Propensity to working in a complex scientific environment with multi-dimensional points of view.
Detail oriented, self-starter, eager to do hands on work to get the job done correctly, on time
Critical thinking and active listening skills
Outstanding written/verbal communication and computer skills coupled with an open, honest and respectful communication style
Proficiency with Microsoft Office Suite
Ability to travel to client locations, domestic and international
Provision Research Compliance offers global consultancy services for the development and implementation of Good Clinical Practice (GCP) and Human Research Protection (HRP) procedural standards and programs for the conduct of clinical research studies. A division of Schulman IRB’s consulting arm, Provision provides the research services industry with the first global compliance organization of its kind, specializing in providing (CQA) and (HRP) consulting services to academic research institutions, hospital systems and CROs.
Provision's experts are experienced in understanding and simplifying complicated regulatory matters. Clients can expect high quality services and proven methodologies that help to minimize regulatory risk. Provision promotes the highest standards of personal integrity, professional competence, sound judgment, quality and discretion in its services and relationships with clients.
About Provision Research Compliance (Consulting Division of Schulman IRB)
SCHULMAN Associates IRB, Inc. (“SCHULMAN“) is dedicated to human research subject protection. Since its beginnings in 1983, Schulman has grown to one of the most prominent independent IRB’s in the country, recognized as a technology and customer service leader.