Compliance Manager - FT - Days - Research Dept

DHR Health - US:TX:Edinburg - Days

Summary:

FLSA STATUS: Exempt Non-Exempt

MISSION STATEMENT:

Our Mission is to improve the well-being of those we serve with a commitment to excellence: every patient, every encounter, every time.

VISION:

Our Vision is to create a world-class health system to advance medicine and increase access for the communities we serve by empowering caregivers to heal through compassion, knowledge, innovation, integrated care and excellence.

POSITION SUMMARY:

Reporting to the Vice President for Research and Development, the Manager, Research Compliance must be deeply familiar with regulatory areas of research compliance related to biomedical research. The Manager of Research Compliance will design, develop, implement, and monitor an effective research compliance program coordinating institutional-wide initiatives to assess, balance and respond appropriately to compliance risks. This position requires working collaboratively and strategically with the DHR Health Institute for Research and Development IRB Administrator and Office of Research Grants and Contracts and DHR Health System administrative offices, including the Offices of Legal Services, Compliance, Education, Environmental Health and Safety, Procurement, Computing, Communications & Information Technologies. The Manager, Research Compliance will review research contracts and manage pre and post-award allocations and ensure compliance with all funding agencies.

POSITION EDUCATION/ QUALIFICATIONS:

• Minimum of Master’s degree in Health Administration with demonstrated work experience
• Moderate professional experience in research administration and/or research compliance
• Computer skills required with knowledge of Microsoft Office suite.
• Excellent written and verbal communication skills required.
• Some evening or weekend work will be required.
• Bilingual – English/Spanish.

JOB KNOWLEDGE/EXPERIENCE:

• Extensive knowledge of federal research regulations pertaining to one or more of the following areas: sponsored projects, research integrity, effort reporting, conflict of interest, human subject research, export control/controlled information, procurement, record retention, etc.
• Knowledge in clinical research contracts and management of pre and post award allocations in compliance with state, federal and private funding agencies.
Knowledge of State, Federal Research guidelines.

Responsibilities:

POSITION RESPONSIBILITIES:

• Promotes the facility mission, vision and values by effectively communicating them to others. Considers mission, vision and values in developing services, standards and practices.
• The Research Compliance Manager provides strategic oversight for and coordination of institutional research compliance programs that promote the highest standards of ethics, integrity and responsibility
• Ability to successfully interpret and explain regulations and guidance given particular situations and audiences; ability to assess regulatory issue impact on institutional business needs, researchers, and research programs;
• Proven success in implementing compliance monitoring mechanisms;
• Exceptional written, verbal and interpersonal communication skills; demonstrated ability to effectively communicate complex issues both verbally and in writing;
• Demonstrated ability to design, develop, and deliver training in research compliance
• Ability to identify and use formal and informal decision-making networks, facilitate reconciliation of conflicts, and negotiate successful solutions.
• Leadership & Oversight: Act as the primary regulatory authority within the Institute, setting the agenda for and overseeing the development, implementation, and enforcement of all SOPs related to clinical research compliance. Serve as the main point of contact for sponsors and handle concerns arising from audits. These can be serious deviations from the standard of research care and require immediate intervention to correct the situation. The incumbent will be part of the Institute’s Leadership and will report directly to a VP or EVP.
• SOP Development & Implementation: Design, implement, and maintain comprehensive SOPs to ensure consistent, compliant practices across the organization. Lead the teaching of SOPs and ensure all staff understand and adhere to these practices. Directly enforce adherence to SOPs and hold staff accountable.
• Compliance Monitoring & Enforcement: Track and monitor compliance with regulatory requirements across all research studies. Enforce compliance through regular assessments, ensuring that deficiencies are addressed promptly. Notify Clinical Research Coordinators (CRCs) of any deficiencies and ensure corrective actions are implemented.
• Performance Management & Tracking: Assess and grade the performance of CRCs based on their adherence to SOPs and compliance requirements. Make input into the continued employment and performance of CRCs within the organization. Assign work to CRCs and ensure they are meeting performance standards.
• Audit & Regulatory Interactions: Serve as the lead liaison between the Institute and external sponsors, handling concerns and communications arising from audits and regulatory reviews. Work closely with sponsors to address any findings, ensuring the Institute’s regulatory posture is protected and strengthened.
• Training & Education: Lead the development and delivery of regulatory training programs across the Institute. Serve as the primary resource for teaching regulatory materials, ensuring all team members are well-versed in compliance requirements and standards.
• Quality Assurance & Control: Design and implement control measures to improve the Institute’s regulatory posture, particularly regarding FDA requirements. Ensure that all regulatory documentation and compliance records for clinical trials are complete and accurate.
• Work Assignment & Workflow Management: Assign tasks and responsibilities to CRCs, ensuring workloads are distributed effectively and timelines are met. Implement compliance schedules to track study progress and ensure that each trial is on track with regulatory requirements.
• Continuous Improvement & Process Optimization: Continuously assess and improve compliance processes, incorporating feedback from audits, CRCs, and sponsors. Proactively identify areas for improvement and design solutions to enhance compliance and efficiency.
• Comprehensive Compliance Coverage: Ensure that all aspects of compliance documentation are completed for all 250 studies, including the required regulatory filings, audit responses, and compliance reports. Collaborate with internal teams to maintain a comprehensive regulatory database.
• Other duties as assigned.

Other information:

CUSTOMER SERVICE:

Provide excellent customer service to all DHR customers. All employees are required to attend the DHR C.A.R.E.S program which outlines the Customer Service Principals including: Commitment, Accountability, Respect, Excellence and Service.

AGE SPECIFIC:

Employees must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served in his/her assigned unit. The individual must demonstrate knowledge of principles of growth and development over the life span and possess the ability to assess data reflective of the patient’s status and interpret the appropriate information needed to identify each patient’s requirement relative to his or her age.

AMERICANS WITH DISABILITIES ACT: (ADA):

A. Essential Duties: Indicated by bold print within performance standards, preceding individual numbered criteria.

The following table provides physical requirements that will be associated with, but not limited to, this position:

B. Working Conditions: The individual spends over 95% of his/her time in an air-conditioned environment with varying exposures to noise. There is protection from weather conditions but not necessarily from temperature changes. The position does have low exposure to malodorous, infectious body fluids from patients and some minimal exposure to noxious smells from cleansing agents.

C. Occupational Exposure: This position has minimal to no exposure to blood, body fluids, or tissues and is an OSHA Category III (although situations can be imagined or hypothesized under which anyone, anywhere, might encounter potential exposure to body fluids). Person who performs these duties are not called upon as part of their employment to perform or assist in emergency medical care or first aid or to be potentially exposed in some other way.

D. Aptitudes: HIGH 1 2 3 4 5 6 LOW

Intelligence: General learning ability: The ability to “catch on” or understand instructions and underlying principles. Ability to reason and make judgments. 3

Verbal: Ability to understand meanings of words and ideas associated with them, and to use them effectively. To comprehend language, to understand relationships between words, and to understand meanings of whole sentences and paragraphs. To present information or ideas clearly. 3

Numerical: Ability to perform arithmetic operations quickly and accurately. 2

Spatial: Ability to comprehend forms in space and understands relationships of plane and solid objects. Frequently described as the ability to “visualize” objects or two or three dimensions, or to think visually of geometric forms. 2

Form Perception: Ability to perceive pertinent details and objects or in pictorial or graphic material to make visual comparisons and discriminations and see slight differences in shapes and shadings of figures and widths and lengths of lines. 3

Clerical Perception: Ability to receive pertinent details and verbal or tabular material. To observe differences in copy, to proofread words and numbers, and to avoid perceptual errors in arithmetic computation. 2

Motor Coordination: Ability to coordinate eyes and hands to fingers rapidly and accurately in making precise movements with speed. Ability to make a movement response accurately and quickly. 3

Finger Dexterity: Ability to move hands easily and skillfully. To work with fingers in placing and turning motions. 3

Manual Dexterity: Ability to move hands easily and skillfully. To work with hands in placing and turning motions. 3

Eye-Hand-Foot Coordination: Ability to move the hand and foot coordinately with each other in accordance with visual stimuli. 3

Color Discrimination: Ability to perceive and respond to similarities or differences in colors, shapes, or other values of the same or different color. To identify a particular color, or to recognize harmonious or contrasting color combinations, or to match color adequately. 3

I have read and reviewed my job description with my supervisor or designee and I understand the job I am expected to perform.

If applicable ____________ certification will be completed within _________ time frame of hire/transfer date.

Employee Signature: ________________________________ Date: ____________________

Transfer/Hire Date Effective: ________________________.