Clinical Research Coordinator II

Advancing Care Through Innovation! Position is on-site Monday - Friday at the clinic in Exton, PA. Clinical Renal Associates 860 Springdale Drive, Suite 100 Exton, PA 19341-2834 The Clinical Research Coordinator II leads the clinical research program at the site level: effectively recruiting and enrolling research patients under the clinical direction of the principal investigator, and always in compliance with institutional Standard Operating Procedures, protocol specifications, and good clinical practice. In addition, proactively develops and implements workflows to optimize recruitment, enrollment, and study execution. Responsibilities Read and understand assigned research protocols, prescreen patients, train site staff on study purpose, record attendance, evaluate resources needed and deploy the study appropriately Proactively recruit potentially eligible patients for research studies, communicate eligibility criteria and flag eligible patients to referring physicians and clinic staff. Work collaboratively with clinic leadership and staff to identify and implement effective processes for communicating study opportunities. Work collaboratively with central research departments, including Central Enrollment Team, to exceed targets for referrals, consents, and enrolled patients. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to the ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All source documents organized and readily available Respond to monitoring letters and resolve outstanding items from prior visits Maintain current temperature and accountability logs Ongoing study oversight and management: Plan subject visits according to protocol‑specific visit schedule and avoid protocol deviations from out‑of‑window procedures Communicate with location administration to ensure space and resources are available as needed Report adverse and serious adverse events to IRB, sponsor, and management per reporting guidelines Dispense and collect study medication and provide accurate investigational product accountability Collect and process subject laboratory specimens according to protocol Complete case report forms (CRFs) and other patient tracking information accurately and on time Maintain thorough understanding of all data collection instruments and collect data accurately per protocol Perform other duties and responsibilities as required, assigned, or requested Qualifications MA certification preferred Bachelor’s degree in health‑related field preferred Good Clinical Practice and/or ITIA certification preferred ACRP or Socra certification preferred Bilingual preferred (Spanish) Minimum 3‑5 years clinical research experience Therapeutic area experience in CKD, nephrology, or vascular access a plus Knowledge of medical terminology and research Self‑motivated individual who drives patient safety, enrollment targets, quality timely data entry, and adherence to Good Clinical Practice (GCP) Excellent interpersonal and communication skills Flexibility, excellent organizational skills, and attention to detail Knowledge of and adherence to GCP, IATA and FDA regulations Ability to perform basic clinical procedures such as blood work, vitals, height, weight, etc. Ability to perform an ECG Ability to multitask and handle a high volume of patients across multiple studies Open to working a flexible schedule The Company is committed to the principles of equal employment. We are committed to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment which is free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy, physical or mental disability, genetic information, veteran status, uniformed servicemember status, or any other status protected by federal, state, or local laws. The company is dedicated to the fulfillment of this policy in regard to all aspects of employment, including but not limited to recruiting, hiring, placement, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment. #J-18808-Ljbffr Panoramic Health