Clinical Operations Manager - Research Billing Servies & Compliance

Overview:

Job Description Summary:

Job Description:

Essential Functions:

• Provides management and oversight of clinical research under designated clinical and inpatient spaces. Ensures compliance with all applicable hospital and research regulations and policies, protection of human subjects, and clinical trial billing policies. Participates in internal audits and maintains documentation for current workflows.
• Manages resources associated and oversees the entire employment lifecycle of clinical research billing staff. Ensures adequate level of staff training to meet performance and quality standards. Acts as a resource for questions and problem solving.
• Provides guidance in all aspects of clinical research billing procedures. Troubleshoots billing issues, including those that have operational, compliance, and regulatory impact. Creates and delivers presentations on clinical research billing practices.
• Oversees participant research billing compliance and provides quality reviews, evaluates study documents, ensures charges are routed, and documented appropriately.
• Identifies requirements and develops reports to meet organizational reporting needs. Provides input into department performance metrics and completes annual metrics reports.
• Maintains current knowledge of federal, local, and institutional hospital and research regulations by serving on hospital committees, reviewing current publications, and attending conferences. Advises department leadership of regulation or policy changes and projects impact to clinical research operations.

Education Requirement:

• BA/BS degree in a related field or equivalent experience in medical/science field, required. 
• Masters, preferred. 

Certifications:

Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators or ability to obtain within 6 months of hire, required.

Skills:

• Demonstrated in-depth knowledge of clinical research, IRB, and regulatory regulations, policies, and procedures.
• Strong verbal, written, and interpersonal communication.
• Skills surrounding being goal-oriented, self-directive, initiation, self-motivation, creativity, and flexibility.
• Ability to lead others; positive attitude; excellent problem-solving skills, highly effective critical thinking skills
• Excellent organizational, attention to detail and prioritization skills
• Demonstrated effective conflict management; provides feedback in a constructive way
• Working knowledge of PCs, word processing, and data management software

Experience:

• 5 years of Clinical Research Administrative experience, required.
• 3 years personnel management experience, required. 5 years preferred.
• 3 years of coordination experience, required. 
• Past position experience requiring analytical and organizational skills to compile and analyze financial data, regulatory/IRB processes, and experience managing multiple activities simultaneously, preferred.
• Experience with CTMS, preferably OnCore, preferred.
• Experience with Epic’s Research Billing module, preferred. 

Physical Requirements:

OCCASIONALLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Climb stairs/ladder, Color vision, Communicable Diseases and/or Pathogens, Depth perception, Electricity, Flexing/extending of neck, Fume /Gases /Vapors, Hand use: grasping, gripping, turning, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Lifting / Carrying: 41-60 lbs, Lifting / Carrying: 61-100 lbs, Loud Noises, Machinery, Patient Equipment, Peripheral vision, Power Tools, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Reaching above shoulder, Seeing – Far/near, Squat/kneel, Working at Heights, Working Outdoors

FREQUENTLY: Cold Temperatures, Hot Temperatures, Standing, Walking

CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Hearing acuity, Interpreting Data, Problem solving, Repetitive hand/arm use, Sitting

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"