Clinical Research Coordinator C (Department of Cardiovascular Medicine)
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Posted Job Title
Clinical Research Coordinator C (Department of Cardiovascular Medicine)
Job Profile Title
Clinical Research Coordinator C
Job Description Summary
This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. They will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner.
Job Description
This position is contingent upon favorable funding.
The Division of Cardiology at Pennsylvania Hospital seeks a full-time Clinical Research Coordinator to organize, coordinate and implement complex studies involving a wide variety of investigational products/devices and various sponsors. S/he will be responsible for all aspects of clinical trial coordination. The coordinator will assist physicians/investigators with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. Sh/e will organize and assist in the preparation of documents and systems needed for initiation, enrollment, monitoring, internal and external auditing, and study close-out visits for complex Phase I-IV clinical trials. They will interface with regulatory authorities, sponsors, CROs, and cooperative groups as directed by the supervisor.
He/she will be responsible for submission of studies to Institutional Review Board (IRB), ongoing maintenance of regulatory documentation including additional applicable reviewing entities per each entity's required timeline, and maintenance of the essential documents binder/TMF. S/her will assist in review of new trials, assist with development of site specific documents (CRFs, SOPs, databases development), help investigators identify the challenges and opportunities, problem-solve the challenges and implement a plan of action to mitigate potential barriers.
He/she will also be responsible for the screening of patients, provision and discussion of informed consent documents, subject enrollment, collection and storage of biological samples and related study documents, implementation and performance of study related procedures and assessments, collection of clinical and research data with proper source documentation and CRF completion, perform accurate data entry to study specified databases, and conduct accountability of investigational product and devices. The coordinator will execute and ensure adherence to the protocol and Good Clinical Practice, while taking an active role in preparation of trial audits and inspection. S/he will provide regular updates to the investigators, research team and other stakeholders as needed. S/he may assist in analyzing clinical data to determine response and clinical outcomes; assist with literature reviews; contribute to the preparation of study abstracts, posters, manuscripts and grant applications. S/he may act as a mentor to coordinators who have joined the unit with less research experience.
Job Responsibilities
Assist in the initiation and conduct of clinical research studies performed by physicians using currently approved protocols, according to Good Clinical Practice. Obtain detailed knowledge start-up activities and of all components of study protocols by review of study protocol, related literature prior to study start date. Assure accurate and timely completion and updating of the Delegation of Duties and Authorized Signatures Form. Create and maintain research data, regulatory files, subject data, billing records, and study database.
Liaison to departmental team-investigators, nurses, coordinators, students and stakeholder as appropriate.
Screen daily to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion Exclusion checklists before introducing opportunity to patient. Recruit patients and explain protocol and consent forms. Assure original signed consents are maintained in the study binder, Complete screening/enrollment logs and submit to sponsor.
Create and maintain a complete and accurate regulatory binder for each study. Assist with preparation and processing of all Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments and adverse event reporting. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms.
Complete study visits with completion of source documents and worksheets within 48 hours of study activity. Complete and/or enter all clinical record forms (CRFs) within 5 working days or less depending on sponsor requirements. Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs in a timely manner.
Review new protocols to identify any challenges; Problem solve the challenges.
Schedule and conduct follow-up visits with patients and assure research team availability to assure all follow-up activities are conducted within sponsor designated timeframes including documentation of lost-to-follow-up efforts. Schedule additional protocol-required tests/procedures.
Monitor adherence to protocol throughout patient enrollment in study. Notify PI, managers, sponsor of any deviations from protocol or adverse events. Assure reported trial data are accurate, complete, verifiable from source documents; collect data on adverse events and reports serious adverse events per regulatory standards. Assure correct version of approved consent is used for each enrollment. Assure timely notification to all enrolled subjects of significant changes in consents.
Other duties and responsibilities as assigned
Qualifications
Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
Position is contingent upon funding
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $70,000.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
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Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
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Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
