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Study Monitor Jobs in Delaware (NOW HIRING)

AstraZeneca

Clinical Research Associate

Wilmington, DE · On-site

The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure delivery and compliance.y. The CRA is responsible for the identification ...

IQVIA

CRA 2, Oncology, IQVIA

Wilmington, DE

$87K - $145K/yr

... monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Collaborate and liaise with study team members for ...

IQVIA

CRA 2, Oncology, IQVIA

Wilmington, DE

$87K - $145K/yr

... monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Collaborate and liaise with study team members for ...

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Study Monitor information

What are the key skills and qualifications needed to thrive in the Study Monitor position, and why are they important?

To thrive as a Study Monitor, you need a strong understanding of clinical trial protocols, regulatory guidelines (such as GCP), and data integrity principles, typically supported by a degree in life sciences or a related field. Familiarity with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and certifications like ACRP or SOCRA are commonly expected. Excellent attention to detail, strong organizational skills, and effective communication are crucial soft skills. These competencies ensure high-quality study oversight, compliance with regulations, and smooth collaboration among clinical research teams.

What are some common challenges Study Monitors face during clinical trials?

Study Monitors often encounter challenges such as ensuring consistent protocol adherence across multiple sites, managing discrepancies in data, and navigating tight timelines for site visits and reporting. They must adapt quickly to evolving regulatory requirements and effectively communicate any issues or deviations to investigators and sponsors. Being proactive in identifying potential risks and fostering strong relationships with site staff can help minimize these challenges. As a result, successful Study Monitors need to be resourceful, detail-oriented, and skilled at balancing regulatory compliance with practical problem-solving in dynamic trial environments.

What is a Study Monitor job?

A Study Monitor, also known as a Clinical Research Associate (CRA), is responsible for overseeing clinical trials to ensure they comply with regulatory guidelines, study protocols, and ethical standards. They monitor site activities, review data accuracy, and ensure participant safety. Study Monitors work closely with investigators, site staff, and sponsors to ensure the integrity of trial results and adherence to Good Clinical Practice (GCP) guidelines.

What are popular job titles related to Study Monitor jobs in Delaware? For Study Monitor jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Study Monitor jobs in Delaware look for? The top searched job categories for Study Monitor jobs in Delaware are:
Study Monitor jobs near you
Clinical Research Coordinator - Orthopedics

Clinical Research Coordinator - Orthopedics

Nemours Children's Health

Wilmington, DE • On-site

$23.50 - $31.25/hr

Full-time

Posted 11 days ago

Nemours Children's Health rating

8.1

Company rating: 8.1 out of 10

Based on 86 frontline employees who took The Breakroom Quiz

68th of 875 rated healthcare providers

Job description


Nemours is seeking a Clinical Research Coordinator to join our Nemours Children's Health team in Wilmington, DE.
The Clinical Research Coordinator coordinates, implements and completes clinical research studies and/or clinical trials in the Orthopedics Department at Nemours Children's Hospital Delaware by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
Essential Functions
  1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
  2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
  3. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
  4. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
  5. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
  6. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
  7. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
  8. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
  9. Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
  10. Participates in continuous process improvement initiatives and implementation of outcomes
  11. Prepares for internal and external audits. Prepares corrective action plans as indicated.

Requirements
  • Bachelor's degree in medical or science related field required
  • 1-3 years research experience
  • Effectively uses Microsoft computer software
  • Demonstrates ability to coordinate and establish priorities among diverse tasks
  • Effectively communicates verbally and in writing

About Us
Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida - along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships.
Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child thrive.
Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued.
Learn more at Nemours.org.

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About Nemours Children's Health

Sourced by ZipRecruiter

Nemours Children’s Health, situated in Rockland, Delaware, US, operates within the healthcare industry. The company is a prominent health system offering pediatric care in Delaware, New Jersey, Pennsylvania, and Florida. It was founded in 1936 by Alfred I duPont, philanthropist and industrialist, to improve the health of children. The core values of Nemours include quality, accountability, respect, and teamwork. Its mission is to provide leadership, institutions, and services to restore and foster a healthy tomorrow for children. The non-profit organization is unique in that its primary focus is on patient families, ensuring the highest standards of pediatric care. Notably, Nemours is consistently ranked among the top children's hospitals in the US and has its own renowned research center, the Nemours Biomedical Research.

Industry

Hospitals

Company size

5,001 - 10,000 Employees

Headquarters location

Rockland, DE, US

Year founded

1936

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