In-House Clinical Research Coordinator

U.S. Urology Partners; Île-de-France; Sur place; EUR 30 000 - 59 000; Plein temps

Avantages offerts par ce poste

Medical plans

Dental plans

Vision plans

HSA / FSA

401(k) matching

Employee Assistance Program (EAP)

Résumé du poste

U.S. Urology Partners is seeking an In-House Clinical Research Coordinator to conduct and document clinical trials in accordance with Good Clinical Practice guidelines. The role requires coordinating a team, recruiting subjects, obtaining informed consent, and ensuring regulatory compliance.

Responsibilities include data handling, adverse event reporting, and collaboration with sponsors to support protocol addenda and audits.

Qualifications

• Bachelor's or Associate degree required.
• GCP Certification required.
• IATA Certificate required.
• CCRC certification (ACRP/SoCRA) required.
• 2–3 years related research experience preferred.

Responsabilités

• Coordinate a team to conduct a minimum of six clinical trials and evaluate/analyze data.
• Recruit study subjects based on protocol criteria.
• Discuss protocols with patients and obtain informed consent.
• Ensure accuracy of source documentation and CRFs per FDA guidelines.
• Report adverse events per study protocol and monitor safety.
• Prepare for sponsor meetings and ensure protocol understanding.

Connaissances

GCP Certificate

IATA Certificate

CCRC Certification

Clinical Research

Formation

Associates or Bachelor's Degree

Description du poste

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 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.

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

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.