Director of Clinical Research Operations-FT- Research Dept
Apply NowCompany: DHR Health
Location: Edinburg, TX 78542
Description:
DHR Health - US:TX:Edinburg - Days
Summary:
FLSA STATUS: Exempt Non-Exempt
MISSION STATEMENT:
To lead and oversee clinical research operations associated with the implementation of approved studies with the utmost commitment to excellence, safety, and patient-centricity, and to drive innovation in clinical research to improve patient outcomes and advance medical knowledge.
VISION:
To lead the way in high-quality clinical research by empowering our team to collaborate effectively, innovate, and optimize operations to improve patient outcomes and advance medical knowledge.
POSITION SUMMARY:
The Director of Clinical Research Operations at DHR Health Institute for Research and Development is responsible for the oversight and management of all clinical research operations involved in the implementation of studies, ensuring compliance with regulatory guidelines, and maintaining a high level of quality in all aspects of clinical trial execution. This position is also responsible for developing and maintaining relationships with sponsors, investigators, and clinical research staff to ensure the success of clinical research projects. The Director of Clinical Research Operations will support the development of clinical research budgets, timelines, and project plans, and work closely with other members of the research leadership team to ensure successful project completion. Additionally, this role involves managing the Clinical Research Coordinator (CRC) workforce, enhancing team productivity, and implementing comprehensive training programs for new and existing staff.
POSITION EDUCATION/ QUALIFICATIONS:
An advanced degree (MD or PhD) with a strong clinical research background, a Master's degree with at least 3 years of related experience, and/or a Bachelor's degree with over 5 years of related experience.
Seven years of experience in clinical research, with five years at the DHR Health Institute for Research and Development.
Knowledge of clinical trial regulations and guidelines, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
Experience managing staff and resources with the ability to provide strategic input and direction for clinical operations to ensure efficient and effective execution of clinical trials.
Experience with budgeting and financial management is preferred.
Software proficiency: Familiarity with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and electronic medical records (EMRs) and other clinical research data management tools is required.
Strong communication and leadership skills.
Ability to work collaboratively with other departments and stakeholders.
Ability to work independently and take initiative, while also functioning as a team player.
Commitment to upholding ethical standards in clinical research and patient care.
JOB KNOWLEDGE/EXPERIENCE:
Strong leadership and management skills to oversee and direct clinical research studies
Thorough understanding of clinical research and regulatory requirements.
Experience with budgeting, forecasting, and resource management.
Software proficiency: Experience with CTMS, EDC, and other systems used in clinical research.
Excellent communication and interpersonal skills to effectively collaborate with team members, stakeholders, and sponsors.
Project management skills: Knowledge of project management principles and tools to effectively manage timelines and deliverables.
Ability to identify and mitigate risks, and solve problems effectively.
Strong analytical and critical thinking skills to evaluate and interpret data.
Commitment to quality and patient safety.
Risk management and quality assurance: Ability to identify and mitigate risks, ensuring quality control throughout the clinical trial process.
Ability to work effectively in a fast-paced, dynamic environment.
Self-starter with the ability to work independently and as part of a team, driving marketing/recruitment initiatives and patient recruitment strategies from conception through execution.
Responsibilities:
POSITION RESPONSIBILITIES:
Oversee and manage the clinical operations for research studies, including but not limited to patient recruitment, study startup, monitoring, and closeout activities.
Patient recruitment strategies: Work with marketing and recruitment teams to develop and implement patient recruitment strategies for clinical trials
Develop and implement policies and procedures to ensure compliance with all regulatory requirements, Good Clinical Practice (GCP), and institutional guidelines.
Supervise and mentor clinical research staff, providing guidance and support to ensure successful study conduct and completion.
Implement comprehensive training programs for new CRCs to ensure they are well-prepared and efficient in their roles.
Enhance CRC team efficiency and research outcomes through effective workforce productivity strategies.
Foster skill development within the CRC team to ensure continuous improvement and adaptation to emerging research methodologies.
Strengthen investigator relationships to promote collaborative research efforts.
Ensure adherence to all regulatory requirements and protocols, maintaining the highest standards of compliance.
Collaborate with the research team to identify potential areas for process improvement and implement solutions.
Risk management: Identify and mitigate operational risks to maintain study integrity and compliance.
Manage study budgets and timelines, ensuring adherence to financial and scheduling requirements.
Foster positive relationships with study sponsors and stakeholders, serving as a point of contact for study-related issues and ensuring clear communication and transparency throughout the study process.
Stay current on emerging trends and best practices in clinical research, proactively identifying opportunities for professional development and sharing knowledge with the research team.
Work collaboratively with other departments and leaders
Other duties as assigned.
Other information:
LINES OF REPSONSIBILITIES:
(Chain-of-command)
1. (Executive Vice President of Research)
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:
Light/moderate lifting up to 20 lbs, from the floor to shoulder height.
Yes
Kneeling
Yes
Must be able to assist other employees with lifting more than 20 lbs.
Yes
Walking
Yes
Light/moderate carrying up to 20 lbs.
Yes
Standing/Squatting
Yes
Straight pulling
Yes
Sitting
Yes
Pulling hand over hand
Yes
Pushing
Yes
Repeated bending
Yes
Stooping/Bending
Yes
Reaching above shoulder
Yes
Climbing Stairs
Yes
Simple grasping
Yes
Climbing Ladders
No
Dual simultaneous grasping
Yes
Depth Perceptions needed
Yes
Ability to see
Yes
Identify Colors
Yes
Operating office equipment
Yes
Twisting
Yes
Operating mechanical equipment
Yes
Crawling
No
Ability to read and write
Yes
Ability to Count
Yes
Ability to hear verbal communication without aid
Yes
Operating Personal Vehicle
Yes
Ability to comprehend written/verbal communication
Yes
Other: Ability to deal with stress
Yes
OSHA Category
III
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. 1
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. 1
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. 3
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. 2
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. 6
Finger Dexterity: Ability to move hands easily and skillfully. To work with fingers in placing and turning motions. 6
Manual Dexterity: Ability to move hands easily and skillfully. To work with hands in placing and turning motions. 6
Eye-Hand-Foot Coordination: Ability to move the hand and foot coordinately with each other in accordance with visual stimuli. 6
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. 6
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: .
Summary:
FLSA STATUS: Exempt Non-Exempt
MISSION STATEMENT:
To lead and oversee clinical research operations associated with the implementation of approved studies with the utmost commitment to excellence, safety, and patient-centricity, and to drive innovation in clinical research to improve patient outcomes and advance medical knowledge.
VISION:
To lead the way in high-quality clinical research by empowering our team to collaborate effectively, innovate, and optimize operations to improve patient outcomes and advance medical knowledge.
POSITION SUMMARY:
The Director of Clinical Research Operations at DHR Health Institute for Research and Development is responsible for the oversight and management of all clinical research operations involved in the implementation of studies, ensuring compliance with regulatory guidelines, and maintaining a high level of quality in all aspects of clinical trial execution. This position is also responsible for developing and maintaining relationships with sponsors, investigators, and clinical research staff to ensure the success of clinical research projects. The Director of Clinical Research Operations will support the development of clinical research budgets, timelines, and project plans, and work closely with other members of the research leadership team to ensure successful project completion. Additionally, this role involves managing the Clinical Research Coordinator (CRC) workforce, enhancing team productivity, and implementing comprehensive training programs for new and existing staff.
POSITION EDUCATION/ QUALIFICATIONS:
An advanced degree (MD or PhD) with a strong clinical research background, a Master's degree with at least 3 years of related experience, and/or a Bachelor's degree with over 5 years of related experience.
Seven years of experience in clinical research, with five years at the DHR Health Institute for Research and Development.
Knowledge of clinical trial regulations and guidelines, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
Experience managing staff and resources with the ability to provide strategic input and direction for clinical operations to ensure efficient and effective execution of clinical trials.
Experience with budgeting and financial management is preferred.
Software proficiency: Familiarity with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and electronic medical records (EMRs) and other clinical research data management tools is required.
Strong communication and leadership skills.
Ability to work collaboratively with other departments and stakeholders.
Ability to work independently and take initiative, while also functioning as a team player.
Commitment to upholding ethical standards in clinical research and patient care.
JOB KNOWLEDGE/EXPERIENCE:
Strong leadership and management skills to oversee and direct clinical research studies
Thorough understanding of clinical research and regulatory requirements.
Experience with budgeting, forecasting, and resource management.
Software proficiency: Experience with CTMS, EDC, and other systems used in clinical research.
Excellent communication and interpersonal skills to effectively collaborate with team members, stakeholders, and sponsors.
Project management skills: Knowledge of project management principles and tools to effectively manage timelines and deliverables.
Ability to identify and mitigate risks, and solve problems effectively.
Strong analytical and critical thinking skills to evaluate and interpret data.
Commitment to quality and patient safety.
Risk management and quality assurance: Ability to identify and mitigate risks, ensuring quality control throughout the clinical trial process.
Ability to work effectively in a fast-paced, dynamic environment.
Self-starter with the ability to work independently and as part of a team, driving marketing/recruitment initiatives and patient recruitment strategies from conception through execution.
Responsibilities:
POSITION RESPONSIBILITIES:
Oversee and manage the clinical operations for research studies, including but not limited to patient recruitment, study startup, monitoring, and closeout activities.
Patient recruitment strategies: Work with marketing and recruitment teams to develop and implement patient recruitment strategies for clinical trials
Develop and implement policies and procedures to ensure compliance with all regulatory requirements, Good Clinical Practice (GCP), and institutional guidelines.
Supervise and mentor clinical research staff, providing guidance and support to ensure successful study conduct and completion.
Implement comprehensive training programs for new CRCs to ensure they are well-prepared and efficient in their roles.
Enhance CRC team efficiency and research outcomes through effective workforce productivity strategies.
Foster skill development within the CRC team to ensure continuous improvement and adaptation to emerging research methodologies.
Strengthen investigator relationships to promote collaborative research efforts.
Ensure adherence to all regulatory requirements and protocols, maintaining the highest standards of compliance.
Collaborate with the research team to identify potential areas for process improvement and implement solutions.
Risk management: Identify and mitigate operational risks to maintain study integrity and compliance.
Manage study budgets and timelines, ensuring adherence to financial and scheduling requirements.
Foster positive relationships with study sponsors and stakeholders, serving as a point of contact for study-related issues and ensuring clear communication and transparency throughout the study process.
Stay current on emerging trends and best practices in clinical research, proactively identifying opportunities for professional development and sharing knowledge with the research team.
Work collaboratively with other departments and leaders
Other duties as assigned.
Other information:
LINES OF REPSONSIBILITIES:
(Chain-of-command)
1. (Executive Vice President of Research)
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:
Light/moderate lifting up to 20 lbs, from the floor to shoulder height.
Yes
Kneeling
Yes
Must be able to assist other employees with lifting more than 20 lbs.
Yes
Walking
Yes
Light/moderate carrying up to 20 lbs.
Yes
Standing/Squatting
Yes
Straight pulling
Yes
Sitting
Yes
Pulling hand over hand
Yes
Pushing
Yes
Repeated bending
Yes
Stooping/Bending
Yes
Reaching above shoulder
Yes
Climbing Stairs
Yes
Simple grasping
Yes
Climbing Ladders
No
Dual simultaneous grasping
Yes
Depth Perceptions needed
Yes
Ability to see
Yes
Identify Colors
Yes
Operating office equipment
Yes
Twisting
Yes
Operating mechanical equipment
Yes
Crawling
No
Ability to read and write
Yes
Ability to Count
Yes
Ability to hear verbal communication without aid
Yes
Operating Personal Vehicle
Yes
Ability to comprehend written/verbal communication
Yes
Other: Ability to deal with stress
Yes
OSHA Category
III
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. 1
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. 1
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. 3
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. 2
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. 6
Finger Dexterity: Ability to move hands easily and skillfully. To work with fingers in placing and turning motions. 6
Manual Dexterity: Ability to move hands easily and skillfully. To work with hands in placing and turning motions. 6
Eye-Hand-Foot Coordination: Ability to move the hand and foot coordinately with each other in accordance with visual stimuli. 6
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. 6
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: .