University of Pennsylvania Perelman School of Medicine
Location
Cherry Hill, Arkansas
Salary
$46,500 - $53,418 / YEAR
The coordinator will manage clinical trials, including patient screening, enrollment, and the collection of clinical data and biological samples. They will also assist with IRB regulatory filings, manuscript preparation, and ensure adherence to FDA and institutional guidelines.
A Bachelor's degree is required, with 1-4 years of related experience in research and clinical study methodologies. Candidates must demonstrate proficiency in regulatory documentation and clinical trial coordination.
Summary This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects
Job Responsibilities: Clinical Research Coordinator A This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.
Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. This position is contingent upon funding. Working Conditions Office, Library, Computer Room; Requires extensive safety Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less Job Responsibilities: Clinical Research Coordinator B Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events Coordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders) Assist in the coordination of Phase I-IV clinical trials Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. Schedule patient visits and any necessary testing. Adhere to all University of Pennsylvania, ICF, and FDA guidelines. Process and ship blood, urine and tissue as required per trial Conduct initiation, monitoring and closeout visits with sponsors and/or CROs Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception requests) Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up Ensure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC) Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow Other duties and responsibilities as assigned.
Bachelor of Science and 2 to 4 years of experience or equivalent combination of education and experience is required. This position is contingent upon grant funding. Working Conditions Office, Library, Computer Room; Requires extensive safety Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less Job Location - City, State Cherry Hill, New Jersey Department / School Perelman School of Medicine Pay Range $46,500.00 - $53,418.00 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, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be 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.
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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