Kerlo Research Inc. is a privately held Site Management Organization (SMO) with a central office located in Monmouth Junction, New Jersey. We work with global pharmaceutical companies and CROs and conduct studies in all major therapeutic areas.
This is a unique and a very exciting opportunity for an individual looking to grow with this site in CRC role, in addition working directly with the central office team leading to Lead Site Manager role.
The successful candidate will be responsible for overseeing and coordinating clinical research activities at our clinical research site or sites, located in Flemington, NJ.
Key Responsibilities:
1. Participant Recruitment and Enrollment:
- Screen and assess potential study participants based on inclusion/exclusion criteria.
- Obtain informed consent from eligible participants and maintain appropriate documentation.
- Enroll eligible participants into clinical trials and ensure compliance with study protocols.
2. Study Coordination:
- Collaborate with principal investigators, physicians, and study sponsors to ensure smooth study implementation.
- Schedule study visits and follow-ups, coordinating with participants and healthcare professionals.
- Collect and manage study data, ensuring accuracy and adherence to regulatory guidelines.
3. Data Management:
- Enter and maintain participant data in electronic data capture systems and study databases.
- Monitor data entry for accuracy, completeness, and timely resolution of data queries.
- Ensure data confidentiality and compliance with data protection regulations.
4. Study Compliance:
- Follow Good Clinical Practice (GCP) guidelines, local regulations, and study protocols.
- Maintain all regulatory documents, including ethics committee approvals and study-related permits.
- Assist with audits, inspections, and monitoring visits from regulatory authorities and sponsors.
5. Participant Care:
- Coordinate participant visits and provide assistance during study-related procedures.
- Monitor participant safety and well-being throughout the study duration.
- Address any adverse events or medical concerns promptly and appropriately.
6. Data Organization:
- Collaborate with clinical research operational team at HQ to collect and organize study data.
- Standardize data formats and procedures for efficient data management across the network.
7. Remote Study Oversight:
- Ensure consistency in study implementation and data collection across multiple sites.
- Provide remote support and guidance to clinical research coordinators and management at other sites.
8. Quality Assurance:
- Conduct data quality checks and identify areas for improvement at individual research sites.
- Collaborate with the Quality Assurance team to address any discrepancies or issues.
9. Training and Education:
- Assist in the development and delivery of training materials for clinical research coordinators at other sites through our Learning Management System.
- Keep a library of industry trends, regulatory updates, and best practices to share with the network.
Qualifications:
- Previous experience as a clinical research coordinator in a clinical research setting.
- In-depth knowledge of clinical research regulations, GCP guidelines, and study protocols.
- Strong organizational and time management skills, with the ability to handle multiple tasks simultaneously.
- Excellent communication skills to interact with participants, investigators, and team members effectively.
- Proficient in using electronic data capture systems and Microsoft Office Suite.
- Flexibility to travel to one or more of the following locations: Flemington, NJ
-Cardiology experience a plus
-EKG & Phlebotomy trained a plus
This role presents an exciting opportunity to contribute to cutting-edge medical research while working in both in-person and remote capacities. If you are passionate about advancing medical knowledge and ensuring the success of clinical trials, we encourage you to apply for this position.
This role is Full Time.
COVID-19 considerations:
All CDC guidelines are properly followed at our workplaces.
Work Location: Flemington, NJ
Job Types: Full-time, Part-time
Pay: $20.00 - $30.00 per hour
Experience level:
- 2 years
- 3 years
- 4 years
- 5 years
Medical specialties:
Schedule:
Ability to Relocate:
- Flemington, NJ: Relocate before starting work (Required)
Work Location: In person