Clinical Research Coordinator A

Clinical Research Coordinator A

This position will assist in the management of multiple clinical trials and responsibilities in Urology. 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.

The day-to-day responsibilities of a CRC-A include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the study to patients and their families, consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing case report forms (CRFs), abstracting data from electronic health records, and conducting telephone visits per protocol; maintaining contact with/tracking study participants per protocol throughout their participation;

inputting data into electronic CRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, Penn Chart, and other study platforms;

regularly reporting study progress to investigators and other managers upon request; storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing; organizing, maintaining, and assuring the accuracy of all study documentation including qualification materials/certifications; and preparing for and participating in study meetings.

Job Responsibilities

• Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
• Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
• Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.
• Oversee study preparation and blood sample processing and analysis
• Database management and analysis
• Ordering and stocking supplies, maintaining equipment
• Educate patients and family members
• Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
• Other duties and responsibilities as assigned

Qualifications

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$47,313.00 - $47,313.00 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.
• Tuition :
  Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here r dependent children are also eligible for tuition assistance at other institutions.
• Retirement:
  Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a…