Responsible for the implementation and support of clinical trials under the auspices of Envision Research. Reports to the Vice President for Research Development and Administration.
Responsibilities include but not limited to:
• Execute and coordinate daily clinical research activities according to the organization’s SOPs, study protocols, GCP and FDA/ICH guidelines. Facilitate, coordinate and release research SOPs and guidelines.
• Complete and maintain regulatory documents required by various regulatory and sponsor entities.
• Serve as the lead contact for study sponsors, governmental agencies, Institutional Review Boards, participating physicians, hospital departments, research staff and patients. Respond to queries in a timely manner.
• Promote Physician relations for clinical research collaborations. Communicate regularly with physician practices for patient referrals.
• Assist Principal Investigators in planning, development and execution of clinical research trials.
• Provide on-site services and protocol-specific training to research staff.
• Provide ongoing monitoring of study procedures and schedule study participants visits according to study protocols.
• Communicate with study participants to obtain and maintain informed consent, compliance with study protocol schedules. Provide education to study participants to ensure understanding of proper medication dosage, administration and treatment.
• Meet/exceed patient enrollment goals while ensuring quality of collected data. Participate in recruitment and selection of medical study participants by interviewing and reviewing medical history, questionnaires and lab results to determine compliance with eligibility requirements.
• Complete case report forms and maintain source documentation per GCP guidelines. Create entries and update research databases.
• Maintain inventory level of all supplies and equipment. • Perform regular internal audits of study records to ensure compliance.
• Obtain blood samples, vitals, and other testing as needed for clinical research studies.
• Assist Business Manager with the review of monthly study-specific financial reports, including study participant billing, to ensure billing compliance. Assist with budget coverage analysis and budget analysis forms according to study protocol procedures.
• Attend Investigator meetings and clinical research training conferences.
• Other duties as assigned.
MINIMUM QUALIFICATIONS AND EDUCATION REQUIREMENTS
Bachelor’s Degree with a minimum two (2) years of experience in clinical research, or an equivalent combination of education and experience required. BS in Nursing preferred. RN credentials and Certification as a Clinical Research Coordinator desirable. Expertise with GCP and FDA/ICH regulations.
REQUIRED KNOWLEDGE SKILLS AND ABILITIES
Excellent communication skills.
Demonstrate excellent organizational skills including attention to detail.
Customer service oriented and possess a team player attitude.
Able to handle effectively and efficiently multiple tasks concurrently and adapt to changes in responsibilities and workloads.
Work and think independently; use sound judgment to solve problems.
Knowledgeable of regulatory requirements.
Possess a high degree of urgency and self-motivation, work ethic, integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other related information.
Utilize proficiently computers and software, such as Microsoft Word, Excel, and Outlook.
Utilize effectively standard office equipment such as phone, photocopier, scanner, and fax machine.
Basic Life Support (CPR) Certification is a plus.
Individuals must possess these knowledge, skills and abilities or be able to explain and demonstrate that the individual can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of skills or abilities and to possess the necessary physical requirements with or without the aid of mechanical devices to safely perform the essential functions of the job.
Degree of Physical Demand (Strength): Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Physical Demands: Positions: Standing, Sitting, Walking, Stooping. Weight/Force: Lifting, Pushing, Carrying, Pulling. Controls: Hand/Arm Foot/Leg: Motor Coordination, Finger Dexterity, Manual Dexterity, Eye/Hand/Foot Coordination.
Type of Physical Activity Required: Acuity, far- Clarity of vision at 20 feet or more. Acuity, near- Clarity of vision at 20 inches or less. Depth Perception – Three-dimensional vision. Ability to judge distance and space relationships so as to see objects where and as they actually are. Field of Vision – Observing an area that can be seen up and in a given point. Accommodation – Adjustment of lens of eye to bring an object into sharp focus. Color Vision – Ability to identify and distinguish colors. Climbing – Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like, using feet and legs and/or hands and arms. Balancing – Maintaining body equilibrium to prevent falling when walking, standing, crouching, or running on narrow, slippery, or erratically moving surfaces. Stooping – Bending body downward and forward by bending spine at the waist. Kneeling – Bending legs at knee to come to a rest on knee or knees. Crouching – Bending the body downward and forward by bending leg and spine. Crawling – Moving about on hands and knees or hands and feet. Reaching – Extending hand(s) and arm(s) in any direction. Handling – Seizing, holding, grasping, turning, or otherwise working with hands. Fingers are involved only to the extent that they are an extension of the hand. Fingering – Picking, pinching, or otherwise working with fingers primarily (rather than with whole hand or arm as in handling.) Feeling – Perceiving attributes of objects such as size, shape, temperature, or texture by means of receptors in skin, particularly those of finger tips. Talking – Expressing or exchanging ideas by means of the spoken word. Hearing – Perceiving the nature of sounds.
Working Conditions: Able to perform work in professional clinic and/or lab environment. Able to adapt easily to changing work priorities. This position might involve travel in Shreveport, Bossier City, Monroe and Ruston areas.
Machines, Tool, Equipment and Work Aids: Requires the use of machines and/or tools specific to applicable position.
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required for the position. Assigned responsibilities and activities may be changed as needed.
To apply, please contact email@example.com.