Clinical Research Assistant- Medical Assistant - Urology of Indiana
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Job Description
The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations.
What You’ll Be Doing
Administratively and clinically coordinates a team to effectively conduct a minimum of six clinical trials(level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results.Schedule, plan, and participate in study monitoring visits and address any potential queries or deviations in accordance with the study contract. Acts as a liaison between the sponsor and the research department.
In collaboration with the Clinical Manager advises treating physicians on clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion, and judgment to include or exclude potential subjects based on trial criteria.
Acts as a study resource for patients and families. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation.
Ensures subjects understanding and willingness to continue participation as well as conduct study-specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients with all treatment option information within their scope of practice such as pamphlets and protocol direction.
Dispenses study medications in accordance with protocol requirements within his/her scope of practice. Performs investigative product accountability for accurate compliance.
Collects, processes, and ships blood/urine specimens at scheduled times.
Supervisors scheduling of research patient visits and procedures consistent with protocol requirements.Performs study-specific procedures, including but not limited to ECGs, vital signs, height, weight, injections, etc. within his/her scope of practice.
Collect, compile, and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy.Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups.
Responsible for the reporting of and follow-up on adverse events and serious adverse events per study protocol.
Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance.
Contacts outside health care providers and communicates with subjects to obtain follow-up information.
Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
Ensures filing and maintenance of all regulatory documents.
Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums.
Maintains required continuing education hours required for certifications.
Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS).
Maintains a high level of patient confidentiality.
Performs all other duties as assigned.
What We Expect from You
Associate's or Bachelor’s Degree from an accredited college or university.
Good Clinical Practice (GCP) Certificate
International Air Transport Association (IATA) Certificate
CCRC certification through an accredited organization (ACRP/SoCRA) is required
2-3 years of related Research ExperiencePreferred.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
To perform this job successfully, an individual should have thorough knowledge in computer information systems.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Travel
Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected.
Benefits We Offer:
Medical
Dental
Vision
Health Savings Account
Life Insurance
Paid Time Off
401K plus Company Match of up to 4%
Accident and Critical Illness Coverage
Long-Term and Short-Term Disability
Employee Assistance Program
What We are Offer You
At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters”
Compassion
Make Someone’s Day
Collaboration
Achieve Possibilities Together
Respect
Treat people with dignity
Accountability
Do the right thing
Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more.
About US Urology Partners
U.S. Urology Partners is one of the nation’s largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery.U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy.
U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.
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