Senior Clinical Research Associate

Title: Senior Clinical Research Coordinator

Reports to: Director of Clinical Research Operations

Location: Newark

Position Type: Full-Time

General Work Hours: Monday – Friday, 8:00am - 5:00pm

About Nephrology Associates, P.A.

Nephrology Associates, P.A. is the largest single specialty practice caring for patients with kidney disease and hypertension in the State of Delaware and Cecil County, MD. Established in 1974, Nephrology Associates has earned the trust of patients and the respect of the local medical community for nearly five decades. Our board-certified nephrologists and mid-level providers are experts in the management of hypertension, chronic kidney disease, acute renal failure, end-stage renal disease, kidney transplantation, kidney stones, and other kidney-related disorders.

Position Summary

The Senior Clinical Research Coordinator will manage clinical trials under the supervision of the Director of Clinical Research Operations and Principal Investigator from study startup through closeout. The ideal candidate will have strong knowledge of GCP, FDA regulations, and clinical trial operations and will serve as a primary contact for sponsors, CROs, investigators, and study participants.

Key Responsibilities

· Manage multiple clinical trials from startup through closeout.

· Coordinate study visits, recruitment, informed consent, and protocol-required procedures.

· Maintain regulatory documents, investigator site files, and IRB submissions.

· Ensure compliance with protocols, ICH-GCP, FDA regulations, and HIPAA requirements.

· Serve as the primary contact for sponsors, CROs, and monitors and coordinate site visits.

· Enter and review study data, resolve queries, and maintain accurate source documentation.

· Manage safety reporting, protocol deviations, investigational product accountability, and study supplies.

· Assist with feasibility, startup, process improvement, and mentoring junior research staff.

To perform in this position successfully, an individual must be able to perform each key responsibility satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Other duties may be assigned to meet business needs.

Required Education and Experience

• Bachelor's degree in a health-related field or equivalent experience.
• Minimum of 5 years of clinical research experience, including independent trial management.
• Strong knowledge of ICH-GCP, FDA regulations, IRB processes, and human subject protections.
• Experience with EDC systems, sponsor/CRO interactions, and monitoring visits.
• Excellent organizational, communication, documentation, and problem-solving skills.

Preferred Experience and Qualifications

• CCRP, CCRC, ACRP-CP, or comparable certification.
• Experience in nephrology, renal, rare disease, cardiovascular, or metabolic research.
• Experience with CTMS and eSource platforms.

Core Knowledge, Skills, and Abilities

· Dynamic and empathetic communication skills to promote trust and confidence from potential research subjects

· Ability to work independently, manage competing priorities, and meet deadlines.

· Strong attention to detail and commitment to research integrity, compliance, and participant safety.

· Professional communication with physicians, participants, sponsors, CROs, and research staff.

· Excellent organizational and time management skills.

· Criminal background investigation and drug testing required.

Physical Requirements

Ability to alternate between sitting, standing, and walking throughout the workday. Must occasionally lift, carry, push, pull, or move study supplies and equipment weighing up to 20 pounds, with or without reasonable accommodation.  

Benefits

In addition to good working conditions and competitive pay, Nephrology Associates, P.A. offers a comprehensive employee benefits program designed to support health, financial security, and work-life balance. As part of this commitment, we constantly strive to offer you a range of benefit plans to help you focus on improving and maintaining your health. Benefit options include health, dental, vision, HSA, life and disability insurance. In addition, other benefits such as PTO, 401(k) with matching and tuition reimbursement are also offered.

How to Apply

Qualified applicants should submit their resume to hr@delawarekidney.com or complete their application via Indeed.

Nephrology Associates, P.A. does not discriminate on the basis of actual or perceived race, religion, color, national origin, ancestry, disability, medical condition, marital status, sex, age, sexual orientation, gender identity or expression, family responsibility, personal appearance, genetic information, matriculation, political affiliation, or any other status protected under law.

Pay: $70,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Application Question(s):

• Do you meet the minimum requirements of this position listed here:
• Bachelor's degree in a health-related field or equivalent experience.
• Minimum of 5 years of clinical research experience, including independent trial management.
• Strong knowledge of ICH-GCP, FDA regulations, IRB processes, and human subject protections.
• Experience with EDC systems, sponsor/CRO interactions, and monitoring visits.
• Excellent organizational, communication, documentation, and problem-solving skills?

Work Location: In person

Salary : $70,000 - $75,000