Provide administrative leadership for the clinical research programs in the Department of Pathology. Develops and implements clinical trial initiatives and supervise day-to-day operations. Essential Functions Works in collaboration with the Principal Investigator to coordinate and implement assigned multiple, complex and/or multi-center clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and provides mentorship to the junior clinical research staff. Responsible f... more details
This is a grant funded position
Position Summary
Provide administrative leadership for the clinical research programs in the Department of Pathology. Develops and implements clinical trial initiatives and supervise day-to-day operations.
Essential Functions
Works in collaboration with the Principal Investigator to coordinate and implement assigned multiple, complex and/or multi-center clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and provides mentorship to the junior clinical research staff. Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. Performs day-to-day activities related to clinical research studies including: recruit and screen participants, obtain informed consent, educate participants regarding study requirements and completes case report forms (CRF). Conducts nursing assessments of clinical trial participants including appropriate reporting. Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with Sponsor guidelines, SOPs and internal and external regulatory agencies. Establish and maintain communications with Investigator, Sponsor and other internal constituents.
Provide administrative leadership over research activities, develop new business opportunities and, in collaboration with local leadership and other UH CRC teams, manage those opportunities from industry sponsor site assessment visits through the clinical trial startup process to study completion. Manage internal and external grants for Pathology Faculty and IRB submissions.
Manage team to conduct of clinical trial processes to ensure high-recruiting clinical trials in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations.
Oversee clinical research staff/CWRU Pathology Work-Study Graduate Medical Assistantship staff and provide educational resources/Identify core competencies and job responsibilities specific to staff positions; and implement program wide projects and provide training efforts for the clinical and research team members; provide research specific educational guidance for attending’s, residents, and fellows. Oversee and implement program wide projects, provide training to the team members, and ensure that team members maintain clinical and research certifications and licensure needed for scope of practice.
Required For All Jobs
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications Education
Bachelor's Degree Required and
Master's Degree . Preferred
Work Experience
5 years Of clinical research experience and past supervisory experience is Preferred and
Experienced in managing trials through the study lifecycle (site assessment, start-up to closure) Required
Knowledge, Skills, & Abilities
Knowledge of project management practices helpful. Required
Results-driven, detail-oriented person with strong understanding of the clinical trial lifecycle, excellent customer service skills and the ability to work independently on multiple tasks and manage time effectively. Required
Strong leadership skills to train and supervise direct reports with effective experience in resource planning. Required
Ability to work consistently and effectively as part of a high performance work team and collaborate effectively with other UHCRC administrative and study teams Good judgment, initiative and problem solving skills. Required
Excellent written communication skills and interpersonal and verbal communication skills. Required
Ability to follow through and consistently demonstrate primary job responsibilities are current. Required
Knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). Required
Licenses and Certifications
Society of Clinical Research Associates (SoCRA) Required and
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