Director Research Operations

1 month ago

Lancaster, United States Lancaster General Full time
Summary
This is an exempt full-time position with a typical 8 am to 5 pm Mon-Friday schedule. Occasional calls or emails may need to be answered very early in the morning, in the evenings or on weekends when emergencies arise. The Director is responsible for all operations oversight and will be in charge of guiding and developing a team of about 20 people including Research nurses, research assistants and an administrative assistant. This is a highly visible position that requires frequent interactions with treating physicians, investigational pharmacists and pharmaceutical companies that sponsor clinical studies. The director is also responsible for managing the research operations cost center.

Job Description

POSITION SUMMARY: The Director of Research Operations is responsible for the management and execution of all clinical studies conducted by the LG Health Research Institute. This position manages the day to day operations of research personnel; oversees research processes and workflows to promote site selection; ensures fast patient recruitment; and executes trials with a quality focus.

ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
  • Conducts feasibility analysis and scopes of potential trials to be conducted at the LG Health Research Institute. Oversees budget and coverage analysis by Research Finance and Billing Compliance Specialist.
  • Manages operational processes and logistical tasks to ensure efficient execution of clinical trials using established resources and within established timelines.
  • Ensures all activities occur in compliance with the appropriate regulations and guidelines for human subject research and for investigational drugs and devices.
  • Improves and implements organizational procedures to facilitate the conduct of clinical research trials with quality outcomes. Manages adherence to procedures and work standards; implements adjustments or changes to work standards; anticipates changes.
  • Works in a team/matrix environment, to collaborate and coordinate with internal and external department staff at various levels, to influence others effectively and to handle multiple responsibilities, tasks and projects simultaneously. Interfaces with ancillary services (i.e. Pharmacy, Lab, Radiology, etc.) to develop collaborative workflows to efficiently execute research.
  • Oversees communications to IRB regarding study initial submissions, renewals, adverse events, and deviations; provides leadership to development of new study processes; oversees screening and enrollment activities
  • With leadership, explores and develops electronic processes to track information on research studies, enrolled patients, and research visits/procedures. Implements processes with study coordinators, supervises the review of research charges by billing specialist.
  • Identifies needs of investigators and health care providers in the conduct of research alongside clinical care. Seeks out patient awareness and enrollment opportunities in health care and community settings; utilizes PR departments of partnering organizations to disseminate information on research studies at start-up and conclusion.
  • Manages and monitors resources, including budget and personnel; establishes priorities in the use of resources including space and equipment.
  • Designs and develops an on boarding and continuous learning / education process for clinical research coordinators to ensure knowledge, skills and abilities are achieved and maintained. Ensures employees have tools and knowledge to comply with research protocol and regulatory requirements. Develops and implements processes that foster employee satisfaction, engagement and retention.
SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:
  • Supports and provides back-up to Research leadership in executing performances.
  • Other duties as assigned.
JOB REQUIREMENTS

MINIMUM REQUIRED QUALIFICATIONS:
  • Bachelor's Degree in Health, Science, Business Administration, Organizational Development, Education, or other related field.
  • Non-profit organizational development experience or transferable knowledge, skills and abilities from for profit medical device or pharmaceutical industry.
  • Experience with all aspects of management of large clinical studies from inception to completion.
  • Knowledge of Regulatory Guidelines, Good Clinical Practices (GCPs).
  • Experience managing professional employees in healthcare organization.
PREFERRED QUALIFICATIONS:
  • Master's Degree in related field.
Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates, and should not be considered absolute. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. Incumbent must be able to perform all job functions safely.

#LI-JC

Benefits At A Glance:

PENN MEDICINE LANCASTER GENERAL HEALTH offers the following benefits to employees:
  • 100% Tuition Assistance at The Pennsylvania College of Health Sciences
  • Paid Time Off and Paid Holidays
  • Shift, Weekend and On-Call Differentials
  • Health, Dental and Vision Coverage
  • Short-Term and Long-Term Disability
  • Retirement Savings Account with Company Matching
  • Child Care Subsidies
  • Onsite Gym and Fitness Classes


Disclaimer

PENN MEDICINE LANCASTER GENERAL HEALTH is an Equal Opportunity Employer, committed to hiring a diverse workforce. All openings will be filled based on qualifications without regard to race, color, sex, sexual orientation, gender identity, national origin, marital status, veteran status, disability, age, religion or any other classification protected by law.

Search Firm Representatives please read carefully: PENN MEDICINE LANCASTER GENERAL HEALTH is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at PENN MEDICINE LANCASTER GENERAL HEALTH via-email, the Internet or directly to hiring managers at Penn Medicine Lancaster General Health in any form without a valid written search agreement in place for that position will be deemed the sole property of PENN MEDICINE LANCASTER GENERAL HEALTH , and no fee will be paid in the event the candidate is hired by PENN MEDICINE LANCASTER GENERAL HEALTH as a result of the referral or through other means.

LGH Full Time Posted on 04/30/2024

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