In-House Clinical Research Coordinator

LE0002 U.S. Urology Partners, LLC; Village of Liverpool (NY); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical plans

Dental plans

Vision plans

HSA / FSA

401(k) matching

Employee Assistance Program (EAP)

Job summary

U.S. Urology Partners is seeking an In-House Clinical Research Coordinator to conduct and document clinical trials in our Research Division in accordance with GCP/ICH guidelines and CFRs.

You will coordinate a team to run multiple trials, monitor visits, recruit subjects, obtain informed consent, and ensure data integrity and regulatory compliance.

Qualifications

• Associates or Bachelor’s Degree from an accredited college or university.
• GCP Certificate
• IATA Certificate
• CCRC certification through an accredited organization (ACRP/SoCRA) is required
• 2-3 years related Research experience
• Reasoning Ability: solve practical problems with limited standardization
• Computer Skills: thorough knowledge in computer information systems

Responsibilities

• Coordinate and conduct clinical trials and related documentation.
• Schedule and participate in study monitoring visits and address deviations.
• Act as liaison between sponsor and research department.
• Recruit study subjects and obtain informed consent per protocol.
• Perform study procedures and data collection within scope of practice.
• Ensure regulatory filing, source documentation, and audit readiness.

Skills

GCP Certificate

IATA Certificate

CCRC certification

Education

Associate or Bachelor's Degree

Job description

About the Role

The In-House Clinical Research Coordinator 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 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 addresses any potential queries or deviations in accordance to the study contract. Acts as a liaison between sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians of 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 family. 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 all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational 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 ECG’s, 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

• Associates 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 related Research experience
• Preferred
• 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 the 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.

What We 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

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.

Salary Range

Salary Range: Please note that the hourly range for this position will vary based on experience level, education and geographical location. $0.00 - $0.00 / hour

Equal Opportunity Employer

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. Our Growth is Creating Great Opportunities! Our team is expanding, and we want to hire the most talented people we can. Continued success depends on it!