Sr. Clinical Research Program Manager

DESIRED QUALIFICATIONS:

• Excellent oral and written communication skills
• Exceptional attention to detail
• Experience with pediatric behavioral, nutrition, and/or community-based participatory research
• Experience with managing multi-site randomized clinical trials
• Experience training, mentoring, and supervising others on topics related to clinical research conduct, management, and regulatory requirements
• Experience auditing clinical research projects
• Training and experience in project management approaches

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

·       Excellent interpersonal skills.

·       Excellent diplomacy skills

·       Proficiency in Microsoft Office and database applications, and EHRs (i.e., REDCap Cloud, EPIC).

·       Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.

·       Knowledge of medical terminology.

·       Minimum of three years of demonstrated managerial experience.

·       Demonstrated disease knowledge / study design experience of studies under purview.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

·       Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.

·       Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.

·       Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Additional PHYSICAL REQUIREMENTS: (remove if none)

WORKING CONDITIONS:

·       May be exposed to blood borne pathogens.

·       May be required to work non-standard, extended or weekend hours in support of research or project work.