What are the responsibilities and job description for the Clinical Research Project Manager - Orthopaedics position at Cleveland Clinic?
Clinical Research Project Manager – Orthopaedics
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. Cleveland Clinic is recognized as one of the top hospitals in the nation. At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation and build a rewarding career with one of the most respected healthcare organizations in the world.
The Clinical Research Project Manager position is vital to managing the Adult Reconstruction portion of the Orthopaedics and Sports Medicine portfolio within the Integrated Surgical Institute. The Clinical Research Project Manager will also serve as a Work Lead to direct the work of research personnel in the Adult Reconstruction section.
A caregiver in this position works 7:30am – 4:00pm.
A caregiver who excels in this role will:
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) within 90 days or hire.
Minimum qualifications for the ideal future caregiver include:
Bachelor’s degree in nursing, general science, a healthcare discipline, or computer science with an emphasis on programming.
Three years of clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate or equivalent management experience in a related field.
The following will substitute the education/experience requirement(s): a high school diploma/GED and seven years of relevant experience, an associate’s degree and five years of relevant experience or a master’s degree and two years of relevant 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.
Preferred qualifications for the ideal future caregiver include:
Associate’s or bachelor’s degree in healthcare or a science-related field. This may substitute for two years of the experience requirement.
Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification.
Supervisory experience.
Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we’re dedicated to providing what matters most to you: https://jobs.clevelandclinic.org/benefits-2/
Physical Requirements:
- Requires full range of motion, manual and finger dexterity and eye-hand coordination.
- Requires standing and walking for extensive periods of time.
- Requires normal or corrected hearing and vision to normal range.
Personal Protective Equipment:
- Follows standard precautions using personal protective equipment as required.
Salary : $1,000 - $1,000,000
