Clinical Research Project Manager - Respiratory

About the role

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.

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.

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

Qualifications

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

Skills

• Full range of motion, manual and finger dexterity and eye-hand coordination
• Standing and walking for extensive periods of time
• Normal or corrected hearing and vision to normal range
• Follows standard precautions using personal protective equipment as required

Benefits

• Health Plan Options – You have the choice between two comprehensive Cleveland Clinic Employee Health Plan options: EHP and EHP Plus. Both plans are administered by Aetna and feature minimal copays for in-network care. Although the benefit designs of EHP and EHP Plus are identical, they differ in their provider network size, with EHP offering a narrow network and EHP Plus providing access to the wide Aetna Open Access Select network. Both plans include access to Cleveland Clinic providers. The health plan also offers Healthy Choice, a voluntary program where participants earn premium discounts for achieving wellness goals.
• Dental Care – Four plan options administered by Cigna are available.
• Vision Care – Two plan options administered by EyeMed are available.
• Flexible Spending Accounts – Healthcare and Dependent Care FSAs are available to help you pay for eligible expenses with pre-tax dollars.
• Life Insurance – Employer-paid life insurance equals 1x your annual salary with an option to purchase supplemental life insurance up to 10x your salary. You may also purchase dependent life insurance for a spouse and dependent children
• Short- and Long-term Disability Coverage – Short-term disability is available after one continuous year of regular full-time service; long-term disability begins after 90 days.
• Cleveland Clinic Investment Pension Plan offers eligible employees an excellent opportunity to build a retirement account for the future. It is fully funded by Cleveland Clinic and equal to 2.5% of your salary (increasing with more years of service).
• The 401(k) / 403(b) Plan also provides an important source of retirement savings. It allows participants to take responsibility for their financial future by making retirement savings a part of their normal routine while working. In addition to your contributions to the plan, Cleveland Clinic matches a portion of your contributions (50% on up to your first 6% in contributions).
• Paid Time Off (PTO) – Eligible caregivers receive Paid Time Off (PTO) that can be allotted toward vacation, holidays, sick time, etc.
• Caregiver discounts – We offer discounted rates for auto, home and pet insurance, identify theft protection and more.
• Adoption assistance – We provide financial assistance of up to $5,000/per child ($10,000 maximum lifetime benefit) for caregivers who choose to legally adopt a child.
• Employee Assistance Program – The Program provides free, confidential short-term counseling for caregivers and their families, whether for relationships or legal challenges.
• Employee Hardship Fund – This fund provides aid for caregivers experiencing unexpected financial difficulties.
• Paid maternity and parental leave – You will enjoy up to eight consecutive weeks for maternal care after the birth of your child to bond with your baby and up to four weeks for parental care.

Pay

Minimum Annual Salary: $63,250.00

Maximum Annual Salary: $96,467.50