Clinical Research Study Coord - FT - Days - Research Dept

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.

• This position will conduct, monitor, and coordinate large multi-center clinical trials in hospital and clinical settings. Responsibilities will be to ensure that the study Investigators adhere to FDA and protocol guidelines. Oversight of research activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects. Gather patient data specified in the study protocol and provide general administrative duties in support of the study. Serve as the main contact with study sponsors or site investigator on data management issues and activities. POSITION EDUCATION/ QUALIFICATIONS­ :
• Bachelor’s degree in related field and/or Qualified Clinical Research Certification or 5 years of related work experience in lieu of bachelor’s degree.
• Basic Life Support Certification required within 6 months from hire/transfer date
• Computer skills required with knowledge of Microsoft Office suite.
• Good written and verbal communication skills required.
• Some evening or weekend work will be required
• Bilingual – English/Spanish. JOB KNOWLEDGE/EXPERIENCE­ :
• Two – five (2-5 ) years of related experience preferred
• Knowledge of randomized controlled trial principles, methodology, and procedures.
• Knowledge of all federal, state and joint commission regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
• Ability to evaluate judgments.
• Ability to analyze and evaluate clinical processes.
• Establish and maintain effective working relationships with physicians, staff members and patients.
• Ability to oversee clinical activities that relate to a large study or project.
• Knowledge of computer application software (Microsoft Office Suite).
• Knowledge of medical terminology.
• Possess excellent verbal and written communications skills in English and Spanish.
• Possess thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical trials.
• Ability to interact with Research staff and Physicians on a daily basis and overlook multi-center clinical trials.
• Ability to effectively manage time and prioritize workload.
• Excellent interpersonal skills; Problem-solving skills.
• Self-starter with the ability to work alone and as part of a team.

• Oversees the Clinical activities for a large complex study involving multiple sites.
• Ensures the adherence of controlled clinical trial protocols.
• Serves as liaison between the study Investigators, nurses, coordinators, pharmacists and assistance for numerous institutions.
• Provides performance management for staff.
• Accompany sponsor personnel on pre-site and clinical site initiation visits with the Principal Investigators.
• Obtain human subject consents.
• Accommodate sponsor personnel during monitoring visits.
• Ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulation, guidelines and policies.
• Ensure appropriate transmission of clinical case data to the sponsor data management centers.
• Reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
• Maintains process and tracking system of protocol related paperwork.
• Coordinates the maintenance of record on study medication and study devices dispensation and inventory usage during the course of the study.
• Ensures Confidentiality of subject records.
• Monitors and records patient response to treatment and communicates study data and results to investigators.
• Maintains and completes source documentation and oversees the preparation of study activity reports for sponsors and investigators as appropriate.
• Prepare regulatory and ethical submissions and procedures to the Institutional Review Boards and study sponsors.
• Implement the clinical trial from initiation through the stages of development documents, tools, organization of facilities and maintain current curriculum vitae and licenses.
• Responsible for the set-up and maintenance of the administrative structure and the infrastructure of the project(s).
• Responsible for the management of study budget.
• Establish and implement protocol Standards of Operations (SOP’s).
• Conduct the financial and contract negotiations at the appropriate management level.
• Negotiate contract terms, pricing and payment schedule, ensuring that the agreements with the vendors/suppliers are commercially advantageous.
• Other duties as assigned. LINES OF REPSONSIBILITIES : (Chain-of-command) 1. (Vice President of Research) → 2. (Executive Vice President of Research) 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.

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. 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: ________________________.