Project Manager II - NCCT Study Start-up Navigator

Hugh Chatham Memorial Hospital; Charlotte (NC); Remote; USD 46,000 - 68,000; Full time

Benefits offered by this job

Paid Time Off

Health and welfare benefits

Educational Assistance Program

Retirement plan with employer match

Job summary

Advocate Health, headquartered in Charlotte, NC, seeks a senior study manager to oversee multi-center trials, coordinate administrative activities, and ensure timely completion of complex research projects. The role emphasizes leadership, budget oversight, and liaison with sponsors and investigators across sites.

Qualifications include a Master's degree in a health-related field and supervisory experience. Remote work is allowed with normal business hours; full-time employment with comprehensive

Qualifications

• Master's degree in Psychology, Nursing, or Basic Science with two years' relevant administrative and medical experience in research projects or other health-related activities; or, an equivalent combination of education and experience.
• One-year experience in a supervisory capacity.

Responsibilities

• Oversees the operational activities at the clinical site(s) and coordinates the activities of a multi-center study or multiple large studies.
• Collaborates with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results. Negotiates protocol changes with funding agency/sponsor.
• Assumes major responsibility for the successful and timely completion of the tasks that comprise the implementation and analysis phases of a multi-center study or multiple studies including planning, development, implementation, and evaluation.
• Coordinates the hiring of and provides direction to support staff. Plans and coordinates training sessions for project personnel located at the different clinical sites. Oversees recruitment, data collection, and follow-up activities.
• Translates planning and design decisions into concrete activities and tasks for project implementation and sets priorities for project implementation.
• Evaluates and interprets collected clinical data. Manages the preparation of progress reports and quality control monitoring; participate in the analysis of study data and the writing of scientific papers for publication.
• Develops data collection forms, procedural manuals, and other documents required for project implementation and evaluation.
• Ensures that all aspects of the following are completed: a. Study is conducted in accordance to the study protocol and contract b. Legal aspects adhere to state and federal regulations and guidelines c. Requirements of the Medical School and the University comply with the conduct of the study d. Technical requirements of the funding agency are met, including auditing requirements
• Conducts site visits to evaluate staff and study activities. Coordinates sponsor audits.
• Represents the project to all related community agencies and organizations, serving as the study's liaison, spokesperson, and representative.
• Conducts meetings and visits with potential study sponsors to promote WFUHS as a study site.
• Attends and participates in national and local meetings related to the planning, operation, and evaluation of the study.
• Assists industry representatives (pharmaceutical, device, etc.) in planning and implementing future studies due to extensive knowledge in the specific field of research.
• Responsible for developing and monitoring the study budget(s). Compiles and prepares financial progress reports. Tracks payments by sponsors, assuring correct amount received for each participant and testing.
• Performs other related duties incidental to the work described herein.

Skills

Communication skills

Scientific principles

Multi-center studies

Education

Master's degree in Psychology, Nursing, or Basic Science

Job description

Department:

10010 NCCT (National Center for Clinical Trials) - Administration

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

• Remote
• Normal Business hours

Pay Range:

$33.05 - $49.60

Job Description:

Under administrative review, performs management level work directed toward the planning, development, implementation, and evaluation of a multi‑center study or multiple large studies. Requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the project. These actions tend to establish precedents and direction for the project(s).

Education/Experience:

• Master's degree in Psychology, Nursing, or Basic Science with two years' relevant administrative and medical experience in research projects or other health‑related activities; or, an equivalent combination of education and experience.
• One-year experience in a supervisory capacity.

Essential Functions:

• Oversees the operational activities at the clinical site(s) and coordinates the activities of a multi‑center study or multiple large studies.
• Collaborates with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results. Negotiates protocol changes with funding agency/sponsor.
• Assumes major responsibility for the successful and timely completion of the tasks that comprise the implementation and analysis phases of a multi‑center study or multiple studies including planning, development, implementation, and evaluation.
• Coordinates the hiring of and provides direction to support staff. Plans and coordinates training sessions for project personnel located at the different clinical sites. Oversees recruitment, data collection, and follow‑up activities.
• Translates planning and design decisions into concrete activities and tasks for project implementation and sets priorities for project implementation.
• Evaluates and interprets collected clinical data. Manages the preparation of progress reports and quality control monitoring; participate in the analysis of study data and the writing of scientific papers for publication.
• Develops data collection forms, procedural manuals, and other documents required for project implementation and evaluation.
• Ensures that all aspects of the following are completed: a. Study is conducted in accordance to the study protocol and contract b. Legal aspects adhere to state and federal regulations and guidelines c. Requirements of the Medical School and the University comply with the conduct of the study d. Technical requirements of the funding agency are met, including auditing requirements
• Conducts site visits to evaluate staff and study activities. Coordinates sponsor audits.
• Represents the project to all related community agencies and organizations, serving as the study's liaison, spokesperson, and representative.
• Conducts meetings and visits with potential study sponsors to promote WFUHS as a study site.
• Attends and participates in national and local meetings related to the planning, operation, and evaluation of the study.
• Assists industry representatives (pharmaceutical, device, etc.) in planning and implementing future studies due to extensive knowledge in the specific field of research.
• Responsible for developing and monitoring the study budget(s). Compiles and prepares financial progress reports. Tracks payments by sponsors, assuring correct amount received for each participant and testing.
• Performs other related duties incidental to the work described herein.

Skills/Qualifications:

• Excellent oral and written communication skills
• Demonstrates knowledge of scientific principles
• Experience in both single- and multi-center studies

Work environment:

• Clean, well lit office environment

Our CommitmenttoYou:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well‑being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• Premium pay such as shift, on call, and more based on a teammate's job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits and more

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, andShort- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.

About Advocate Health

Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.