Wills Eye Hospital
Clinical Research Coordinator
Wills Eye Hospital, Phila, Pennsylvania, United States, 19117
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. About the Organization Wills Eye Hospital, located in Philadelphia, Pennsylvania, is a global leader in the treatment of eye disease. Established in 1832 as the America's first eye hospital, we are one of the world's premier eye care facilities and the #2 best hospital in the nation for ophthalmology as ranked by U.S. News & World Report.
Our clinical expertise, state-of-the-art diagnostic testing and advanced surgical capabilities make Wills Eye a worldwide referral center where more than 250,000 patients are treated annually. From common eye problems to rare sight-threatening diseases, Wills Eye provides general eye care and comprehensive ophthalmic specialty services that attract patients throughout the Philadelphia metropolitan area, across the country and around the world.
Today, we continue to shape the science and medicine of ophthalmology, thanks to our talented, skilled physicians and staff who are dedicated to improving and preserving sight.
Description Primary Function:
The Clinical Research Coordinator is responsible for managing complex clinical trials in accordance with FDA and GCP guidelines. This position will provide support to the Glaucoma Research Center as well as the Vision Research Center.
Essential Duties and Responsibilities:
Glaucoma Research Center:
Primary Function:
Under minimal supervision, the Clinical Research Coordinator provides a moderate to advanced range of activity coordination, supporting multiple research studies in the Glaucoma Service Department.
Responsibilities:
Works closely with the Principal Investigators and study team to identify problems and develop solutions.
Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.
Ensures compliance with the protocol and regulatory requirements, including collecting, recording, and maintaining data and source documentation.
Promotes good clinical practice in the conduct of clinical investigations, including possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection.
Retains records/archives documents after study close out.
Performs ophthalmic photography and diagnostic services using state-of-the-art technologies.
Communicates effectively with subjects, research team, Principal Investigators, ancillary staff, and study sponsors.
Possesses the ability to handle confidential matters. Adheres to all HIPAA guidelines and regulations.
Acquires images of medical phenomena of the eye to document diseases, surgeries, treatments, and congenital problems.
Vision Research Center:
Primary Function:
Under general supervision of the Principal Investigator and Manager of Clinical Research, the Clinical Research Coordinator manages complex clinical trials in accordance with FDA and GCP guidelines.
Responsibilities:
Responsible for overall coordination of site specific clinical trial activities.
Responsible for maintaining ongoing communication with the study team, sponsor, CROs, other relevant entities at Wills, (e.g. IRB, finance) and study subcontractors, including scheduling routine study team meetings.
Manages and participates in all aspects of sponsored clinical trial preparation, start up and implementation, including obtaining informed patient consents, patient screenings for eligibility, enrolling/monitoring study patients in an outpatient setting, and ensuring protocol compliance.
Reviews protocols with PI and makes all necessary preparations for the study.
Schedules subject visits and any necessary testing.
Monitors subjects per protocol requirements and ensures adherence to all protocol requirements.
Assists with preparation and filing of Institutional Review Board (IRB) applications and responses to inquiries.
Organizes and maintains complete and accurate study documentation, including regulatory binders, and all documentation required by the sponsor including source documentation, case report forms, and research charts.
Assumes responsibility for all documenting, adverse events reporting, and maintenance of regulatory files with accuracy and timeliness.
Collects, reviews, and reports study data to the sponsor, completes case report forms and submits to EDC, resolves data queries, processes and ships study specimens including blood and tissue samples.
Documents all communications between patients, investigators, monitors and sponsor related to specific study and files with CRF, subject source document and regulatory binder.
Works closely with the Principal Investigator, Clinical Trials Manager, and study team to identify problems relating to study conduct (e.g., recruitment, follow-up and staffing) and develop solutions. Implement approved changes to procedures as needed and monitor results.
Schedules, assists in preparing for and participates in on-site visits with the sponsor, including initiation, monitoring, audit and close-out visits.
Schedules and participates in study team meetings and ongoing protocol training/compliance meetings.
Ensures patient safety, protocol compliance, and data quality.
Serves as a liaison between the patient, investigator, IRB, and study sponsor in an effective and timely manner.
Closes the study with the sponsor and stores study records appropriately.
Applies knowledge of regulatory processes, including Institutional Review Board (IRB) and Good Clinical Practice (GCP), to all aspects of study conduct.
Adheres to all hospital, FDA, and GCP guidelines. Position Requirements Qualifications
Educational requirements:
Bachelor's degree and 4-5 years of related experience or equivalent combination of education and experience. Licensure/Certification: CCRP or CRA certification strongly preferred Skills & Attributes: Knowledge of FDA and IRB requirement for drug and device research protocols. Effective verbal and written communication skills and strong analytical, organizational and interpersonal skills. Ability to work within a team environment as well as independently. Commitment to continuous learning as required. Ability to make decisions independently. Ability to manage time, multi task and prioritize work. Ability to identify, analyze and solve problems; ability to work well under pressure; knowledge of IRB and human research protection regulations. Exhibits a cooperative attitude toward patients, co-workers, and investigators. Maintains a professional appearance and professional work environment Effectively communicates on appropriate information on project status, unresolved problems and issues involving departments and companies. Displays willingness to assist co-workers in the interest of meeting group goals. Ophthalmic experience strongly preferred Working conditions
Works in a clean, well-lit, ventilated work area.
Physical requirements
Walking and standing; stooping, bending, balancing and sitting. The employee should be in good health and fit enough to handle heavy workloads and other strenuous activities. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Category Research Full-Time/Part-Time Full-Time Position Clinical Research Coordinator Number of Openings 1 Exempt/Non-Exempt Exempt Location Wills Eye Hospital This position is currently accepting applications.
Our clinical expertise, state-of-the-art diagnostic testing and advanced surgical capabilities make Wills Eye a worldwide referral center where more than 250,000 patients are treated annually. From common eye problems to rare sight-threatening diseases, Wills Eye provides general eye care and comprehensive ophthalmic specialty services that attract patients throughout the Philadelphia metropolitan area, across the country and around the world.
Today, we continue to shape the science and medicine of ophthalmology, thanks to our talented, skilled physicians and staff who are dedicated to improving and preserving sight.
Description Primary Function:
The Clinical Research Coordinator is responsible for managing complex clinical trials in accordance with FDA and GCP guidelines. This position will provide support to the Glaucoma Research Center as well as the Vision Research Center.
Essential Duties and Responsibilities:
Glaucoma Research Center:
Primary Function:
Under minimal supervision, the Clinical Research Coordinator provides a moderate to advanced range of activity coordination, supporting multiple research studies in the Glaucoma Service Department.
Responsibilities:
Works closely with the Principal Investigators and study team to identify problems and develop solutions.
Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.
Ensures compliance with the protocol and regulatory requirements, including collecting, recording, and maintaining data and source documentation.
Promotes good clinical practice in the conduct of clinical investigations, including possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection.
Retains records/archives documents after study close out.
Performs ophthalmic photography and diagnostic services using state-of-the-art technologies.
Communicates effectively with subjects, research team, Principal Investigators, ancillary staff, and study sponsors.
Possesses the ability to handle confidential matters. Adheres to all HIPAA guidelines and regulations.
Acquires images of medical phenomena of the eye to document diseases, surgeries, treatments, and congenital problems.
Vision Research Center:
Primary Function:
Under general supervision of the Principal Investigator and Manager of Clinical Research, the Clinical Research Coordinator manages complex clinical trials in accordance with FDA and GCP guidelines.
Responsibilities:
Responsible for overall coordination of site specific clinical trial activities.
Responsible for maintaining ongoing communication with the study team, sponsor, CROs, other relevant entities at Wills, (e.g. IRB, finance) and study subcontractors, including scheduling routine study team meetings.
Manages and participates in all aspects of sponsored clinical trial preparation, start up and implementation, including obtaining informed patient consents, patient screenings for eligibility, enrolling/monitoring study patients in an outpatient setting, and ensuring protocol compliance.
Reviews protocols with PI and makes all necessary preparations for the study.
Schedules subject visits and any necessary testing.
Monitors subjects per protocol requirements and ensures adherence to all protocol requirements.
Assists with preparation and filing of Institutional Review Board (IRB) applications and responses to inquiries.
Organizes and maintains complete and accurate study documentation, including regulatory binders, and all documentation required by the sponsor including source documentation, case report forms, and research charts.
Assumes responsibility for all documenting, adverse events reporting, and maintenance of regulatory files with accuracy and timeliness.
Collects, reviews, and reports study data to the sponsor, completes case report forms and submits to EDC, resolves data queries, processes and ships study specimens including blood and tissue samples.
Documents all communications between patients, investigators, monitors and sponsor related to specific study and files with CRF, subject source document and regulatory binder.
Works closely with the Principal Investigator, Clinical Trials Manager, and study team to identify problems relating to study conduct (e.g., recruitment, follow-up and staffing) and develop solutions. Implement approved changes to procedures as needed and monitor results.
Schedules, assists in preparing for and participates in on-site visits with the sponsor, including initiation, monitoring, audit and close-out visits.
Schedules and participates in study team meetings and ongoing protocol training/compliance meetings.
Ensures patient safety, protocol compliance, and data quality.
Serves as a liaison between the patient, investigator, IRB, and study sponsor in an effective and timely manner.
Closes the study with the sponsor and stores study records appropriately.
Applies knowledge of regulatory processes, including Institutional Review Board (IRB) and Good Clinical Practice (GCP), to all aspects of study conduct.
Adheres to all hospital, FDA, and GCP guidelines. Position Requirements Qualifications
Educational requirements:
Bachelor's degree and 4-5 years of related experience or equivalent combination of education and experience. Licensure/Certification: CCRP or CRA certification strongly preferred Skills & Attributes: Knowledge of FDA and IRB requirement for drug and device research protocols. Effective verbal and written communication skills and strong analytical, organizational and interpersonal skills. Ability to work within a team environment as well as independently. Commitment to continuous learning as required. Ability to make decisions independently. Ability to manage time, multi task and prioritize work. Ability to identify, analyze and solve problems; ability to work well under pressure; knowledge of IRB and human research protection regulations. Exhibits a cooperative attitude toward patients, co-workers, and investigators. Maintains a professional appearance and professional work environment Effectively communicates on appropriate information on project status, unresolved problems and issues involving departments and companies. Displays willingness to assist co-workers in the interest of meeting group goals. Ophthalmic experience strongly preferred Working conditions
Works in a clean, well-lit, ventilated work area.
Physical requirements
Walking and standing; stooping, bending, balancing and sitting. The employee should be in good health and fit enough to handle heavy workloads and other strenuous activities. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Category Research Full-Time/Part-Time Full-Time Position Clinical Research Coordinator Number of Openings 1 Exempt/Non-Exempt Exempt Location Wills Eye Hospital This position is currently accepting applications.