CLINICAL RESEARCH COORD B
Duties: The primary responsibility of the Clinical Research Coordinator B position is to implement study protocols and data collection procedures and to coordinate and support observational studies (both quantitative and qualitative studies). There may also be opportunities to participate in the coordination of Phase I-IV clinical trials. The ideal candidate for this position will have the ability to handle of variety of observational and clinical trial related responsibilities in accordance with the University of Pennsylvania, GCP, ICF, and FDA guidelines. The candidate will participate in study recruitment efforts, writing IRB protocols, and maintaining the regulatory elements of studies. The candidate will also have an opportunity to participate in basic quantitative and qualitative data analysis. The candidate 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.
The responsibilities of the Clinical Research Coordinator B include but are not limited to:
* Draft informed consent forms, data collection forms, protocol revisions and advertisements for regulatory submissions
* Prepare components of IRB submissions 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:
* Basic database creation and management (e.g., REDCap)
* Lead development of CRFs for new studies by reviewing and adapting previous study CRFs
* Coordinate efforts and feedback between study team and more complex database developers
* Review data queries and identify and resolves discrepancies
* Assist with data cleaning and data analysis preparation efforts (quantitative and qualitative data)
* Work with team to address identified data discrepancies and/or other performance issues
* Track and compile completed study visit for sponsor invoicing
* 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
* 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 communication with research staff at external departments
* Recruits, screens and enrolls potential study patients as specified per protocol and implements all study visits and related activities.
* Schedules patient visits, coordinating all visit components with multiple departments.
* Participates in the necessary financial aspects of patient study participation, including distribution of participant compensation and review of bills for accuracy.
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
* Work with providers and study participants on the completion of CRFs and source documentation for study assessments, questionnaires, and other data collection procedures
* Initiate and complete the required financial procedures and documentation, including proper scheduling of research procedures, for the distribution of participant compensation
* 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
* 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 which may include assisting with the collection of and handling of human specimens.
Qualifications: The qualifications required for the Senior Research Coordinator position include:
* Minimum of a BS/BA and 2-4 years experience in clinical research or an equivalent combination of education and experience.
* Knowledge of IRB and Human Research Protection Regulations
* Experience working directly with patients
* Ability to follow detailed clinical research protocols
* Excellent communication and interpersonal skills
* Excellent organization skills and demonstrated attention-to-detail
* Ability to work independently with minimal to moderate supervision
* Ability to multi-task and be flexible in both task and schedule including possibilities of night/weekend work
* Proficient with Microsoft Office Suite and electronic database management
Reference Number: 40-28306
Salary Grade: 026
Employment Type: Exempt
Job Family: I-Technical/Professional Research