Clinical Research Project Manager - Pediatric Hematology-Oncology
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What you'll do
- 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.).
What they're looking for
- 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 have
- Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
- Grant submission and post-award experience
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.
We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One.
Job Title
Clinical Research Project Manager - Pediatric Hematology-Oncology
Location
Cleveland
Facility
Cleveland Clinic Main Campus
Department
RES Research Administration-Research Innov and Educ
Job Code
T26213
Shift
Days
Schedule
8:30am-5:00pm
Job Summary
Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/Manages daily organization and operational issues/activities related to Phase I-IV clinical research trials. Facilitates key trial communications for academic coordination, provides clinical perspective to the design and conduct of clinical trials.
Job Details
Join Cleveland Clinic Research, where you will work alongside passionate caregivers and make a lasting, meaningful impact on patient care. Here, you will receive endless support and appreciation while building a rewarding career with one of the most respected healthcare organizations in the world.
Groundbreaking discoveries happen every day at Cleveland Clinic. As a Clinical Research Project Manager, you will interact with various research teams and play a crucial role in managing the clinical research that allows Cleveland Clinic to continue to innovate and drive better outcomes for patients. Clinical research is the only way that medicine comes on the market, pushing the edge of moving medicine forward. Come join a culture devoted to pushing the needle forward in healthcare.
In Pediatric Hematology and Oncology you will support research and clinical trials for our youngest cancer patients. Learn more here
A caregiver in this role works days from 8:30am-5:00pm. Start/end times may vary.
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) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic.
Perform other duties as assigned.
Minimum qualifications for the ideal future caregiver include:
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
Preferred qualifications for the ideal future caregiver include:
Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
Grant submission and post-award experience
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.
The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.
Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.
Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.
If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/
Please review the Equal Employment Opportunity poster.
Cleveland Clinic is pleased to be an equal employment opportunity employer.
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