Clinical Research Project Manager A

Clinical Research Project Manager A

Job Description

Job Responsibilities

The Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Department of Radiology Clinical Imaging Service Center (RADCORE). The person will work closely with the RADCORE Program Manager to support a diverse group of investigators and coordinators, involving work on a wide spectrum of investigator and industry initiated clinical trials of varying complexities. Involvement will range from consulting to serving as the project manager for a study having primary responsibility with respect to execution and operational planning of the studies and accountability for results.

The Project Manager will manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Investigator/Sponsor, study team and in accordance with all regulatory organizations. S/he will play a key role in study start-up, intake & feasibility for many studies.

The Project Manager will provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance. S/he will generate study specific plans and documents, provide input and management of study budgets, and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. S/he will lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues. S/he will provide leadership and guidance to research personnel in their day-to-day operational activities. S/he will perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks. S/he will participate in documentation of best practices and SOPs.

Job Responsibilities

Manages project/program activities and implements protocols; develops, implements and manages work plans and timeframes in order to ensure project goals.

Communicates project/program activities to ensure clear, coordinated project related communications

Supervises assigned research support and or laboratory personnel; delegates and coordinates tasks based on developed plans

Provide technical leadership and consultation related to project/grant proposals/ manuscripts/animal protocol development, advises those associated with projects (PI) regarding project status

Oversee the delivery of patient care as defined in the study protocols and manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Investigator/Sponsor, study team and in accordance with all regulatory organizations.

Play a key role in study start-up, intake & feasibility for many studies

Provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance.

Generate study specific plans and documents, provide input and management of study budgets. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

Lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues.

Provide leadership and guidance to research personnel in their day-to-day operational activities.

Perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks.

Participate in documentation of best practices and SOPs.

Other duties and responsibilities as assigned.

Contingent Upon Grant Funding

Qualifications

• Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required. Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem-solving skills necessary.

• Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously.

• Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions.

• Flexibility and the drive to meet project deadlines required. Knowledge of regulatory processes is required.

• Excellent written and verbal skills required.

• Job Location - City, State

• Philadelphia, Pennsylvania

• Department / School

• Perelman School of Medicine

• Pay Range

• 63,085.00 - 70,958.00 Annual Rate

• Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

• Equal Opportunity Statement

• The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

• Special Requirements

• Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

• University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

• Time Away from Work: Penn provides you with a substantial am