The primary responsibility of the Clinical Research Coordinator B position is to implement study protocols and data collection procedures with patients for Phase IV clinical trials and observational studies with guidance from senior clinical research staff. The ideal candidate for this position will have the ability to handle a variety of clinical trial related responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines. In addition, this person should have excellent communication skills, experience interacting directly with patients in clinical settings, and demonstrate the ability to direct his/her own work with minimal to moderate supervision.
DUTIES: The responsibilities of the Clinical Research Coordinator B include but are not limited to:
Recruitment: • Identify and implement strategies to ensure successful patient recruitment and enrollment goals are met within specified timelines including but not limited to development of study brochures, outreach to clinics and private providers, print and radio advertisements and internet advertisement. • Initiate and maintain communications with health care providers and staff at local health care clinics and private practices in an effort to obtain patient referrals • Triage interest inquiries (via telephone, email, or in-person encounters) and prescreen potential participants
Enrollment: • Schedule and coordinate screening/enrollment visits • Perform screening procedures per study protocol including approaching participants in clinic or by phone, requesting and reviewing medical records, and asking eligibility questions • Complete informed consent procedures with patients during standard of care clinic visits as well as during scheduled research encounters • Track recruitment and enrollment progress at Penn and external study sites and prepare weekly updates for the research team • Coordinate components of training and monitoring activities for external study sites • Coordinate communication with research staff at external study sites
Visit implementation/data collection: • Schedule and coordinate all study data collection visits with various Penn clinics/providers and departments for patient baseline, follow up, and end of study visits • Serve as main point of contact for study participants • Collect and record patient demographics, social histories, vitals, concomitant medications, and other relevant data • Collect blood samples by performing venipuncture or coordinating visits to outpatient labs • Collect saliva and urine samples • Work with providers on the collection of skin biopsies and prepare samples for processing and storage • Track and maintain records of biospecimens and PET/CT scans • Work with providers and study participants with the completion of CRFs and source documentation for study assessments, questionnaires, and other data collection procedures • Communicate with PennIDS to track study drug inventory, place orders, and ensure proper drug storage and timely shipping of study drug to external study sites • Communicate with external sites to ensure proper packaging and delivery of laboratory specimens to Penn and NIH • Initiate and complete the required financial procedures and documentation, including proper scheduling of research procedures, for the distribution of participant compensation
Regulatory: • Draft informed consent forms, data collection forms, protocol revisions and advertisements for regulatory submissions • Prepare components of IRB documentation such as institutional forms, FDA forms, continuing review and modification submissions, deviation and exception memos, and adverse events reporting • Prepare components of all external study site regulatory documentation including Investigator Agreements, FDA forms, CITI trainings, Investigators’ CVs and medical licenses. • Assist senior clinical research staff in communications with study sponsors and to provide proper documentation and enrollment updates
Data entry and monitoring: • Lead development of CRFs for new studies by reviewing and adapting previous study CRFs • Coordinate efforts and feedback between study team and database developers • Review data entry efforts by junior coordinators and external study sites for timelines and accuracy • Review data queries and identify and resolves discrepancies • Assist with data cleaning and data analysis preparation efforts • Conduct monitoring and closeout visits with external study sites and compile reports • Work with sites to address identified data discrepancies and/or other performance issues • Track and compile completed study visit for sponsor invoicing • Assist with review of invoices from external study sites
Other responsibilities: • Support and interact with PIs, co- investigator, research managers, and other CRCs and staff • Prepare components of MOPs, lab manual, and other guidance documentation for new studies • Oversee inventory maintenance at Penn and at external sites to ensure timely ordering and shipment of supplies • Attends study related meetings • Maintain all relevant trainings and certifications (CITI, GCP, PENN CRC certificate and assigned Penn Profiler trainings) • Adhere to all University of Pennsylvania, GCP, and FDA guidelines • Perform additional duties as assigned.