Clinical Research Project Manager - Respiratory

Cleveland Clinic

2d•Onsite

About The Position

Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. As a Clinical Research Project Manager, you will oversee the administrative functions of the Integrated Hospital Care Institute research portfolio, specifically Pulmonary Medicine, and support a growing team of coordinators. In this role, you will train and support coordinators while managing a broad range of research projects as the Respiratory Institute continues to expand. You will coordinate and manage daily operations and organizational activities related to Phase I to IV clinical trials, facilitate key communications for academic coordination, and provide clinical insight to support the design and conduct of clinical studies. A caregiver in this role works days from 8:00 a.m. – 5:00 p.m.

Requirements

Bachelor’s Degree in Nursing, Science, Healthcare or Computer Science with an emphasis on programming and three years of clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate or equivalent in a related field OR High School Diploma/GED and seven years of experience OR Associate’s Degree and five years of experience OR Master’s Degree and two years of experience
Substantial scientific and medical knowledge across relevant therapeutic areas
Demonstrated ability to work with multiple software technologies
Knowledge of FDA regulations, GCPs and internal SOPs
Knowledge of the Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials
Background/ability or working with clinical studies and clinical research team members at all levels.
Within 90 days of hire, must successfully complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic.

Nice To Haves

Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
Supervisory experience

Responsibilities

Oversee the administrative functions of single and/or multi-institutional research trials.
Coordinate/manage daily organization and operational issues/activities related to Phase I-IV clinical research trials.
Facilitate key trial communications for academic coordination.
Provide clinical perspective to the design and conduct of clinical trials.
Manage and coordinate a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis.
Interact with the Finance and Legal Departments to facilitate clinical trial budget, site budget and contract execution.
Maintain professional relationships with sponsors, including frequent, open communication and associated documentation.
Coordinate development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA.
Collect and review regulatory documents from sites.
Communicate with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues.
Organize, coordinate, attend and participate in Investigator Meetings and training programs.
Develop and maintain planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.).
Analyze site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites.
Assess investigator and site performance.
Lead initiatives to improve quality and make recommendations to discontinue sites if necessary.
Assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
Complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic.
Perform other duties as assigned.