Clinical Research Coordinator II

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 on-hand to appropriately deploy the study
• Proactively recruit potentially eligible patients for research studies by communicating eligibility criteria and flagging potentially 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 to patients and providers. Work collaboratively with central Research departments, including Central Enrollment Team, to meet and 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 ALCOA principle ("Attributable, Legible, Contemporaneous, Original and Accurate")
• Prepare for monitoring visits:
  • All Source Documents organized and readily available.
  • Responds in a timely fashion to monitor letters assuring all outstanding items from prior monitoring visit are resolved.
  • No open queries from prior visit.
  • Temperature and accountability logs are kept current and readily available.
• Ongoing Study oversight and management:
  • Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures.
  • Communication with location administration to make sure space and other resources are available as needed.
  • Reporting of Adverse and Serious Adverse Events to IRB, Sponsor and management in accordance with reporting guidelines.
  • Dispensing/collecting study medication and providing accurate Investigational Product accountability.
  • Collecting and processing subject laboratory specimens according to protocol.
  • Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned.
  • Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol
• Communication with location administration to make sure space and other resources are available as needed
• Reporting of Adverse Events to IRB, Sponsor and management in accordance with reporting guidelines
• Dispensing and collecting medication and providing accurate Investigational Product accountability
• Collecting and processing subject laboratory specimens according to protocol.
• Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned.
• Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to 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 year's to 5 year's clinical research experience
• Therapeutic area experience in CKD, nephrology, or vascular access a plus.
• Must have knowledge of medical terminology/ research
• Self-motivated individual who will drive patient safety, achievement of enrollment targets, quality timely data entry, and adherence to Good Clinical Practice (GCP).
• Requires excellent interpersonal and communication skills.
• Requires flexibility, excellent organizational/communication skills, and attention to detail.
• Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations.
• Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc.
• Must be able to do an ECG.
• Must be able to multitask, able to 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 (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), 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, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment

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