Clinical Research Associate

Mindlance; Charleston (SC); Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Research Associate to ensure the rights and wellbeing of trial participants. This remote role, based in the Charleston area, involves managing site relationships and ensuring clinical trials comply with regulatory standards. You will collaborate with various stakeholders to facilitate timely project delivery and monitor investigational sites throughout all trial phases. If you have a strong background in clinical research and a passion for contributing to innovative treatments, this opportunity is perfect for you.

Qualifications

• Graduate in a clinical or life sciences-related field.
• 2-3 years of experience as a Clinical Research Associate preferred.

Responsibilities

• Build relationships with site personnel for efficient management of trials.
• Monitor investigational sites as per ICH GCP and CMP.

Skills

Clinical Research

Time Management

Interpersonal Skills

Attention to Detail

Education

Degree in Clinical or Life Sciences

Job description

Remote – but based in the Charleston Area for Site Visits

Client Facing at times

Pay – 50-55/hr

Location: Charleston, SC

40 hours – no OT unless approved

Contract – 12 months

About the Role

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from source documents. The CRA serves as the primary contact between Investigational Sites, Novotech, and the Sponsor. A key responsibility is managing site relationships to ensure clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Responsibilities

1. Build relationships with Principal Investigators, study coordinators, pharmacists, and relevant site personnel to ensure efficient, expedited, and smooth management of clinical trials.
2. Foster internal and external customer relationships to ensure focus on efficient, timely, and productive project delivery according to study requirements and timelines.
3. Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submissions and approvals as needed.
4. Understand the requirements of applicable local and international regulatory standards in collaboration with the Regulatory Start-up (RSU) Team.
5. Ensure participant recruitment aligns with site targets. Drive recruitment and engagement initiatives and develop or update site-specific recruitment plans.
6. Monitor investigational sites as per ICH GCP §5.18 and the Clinical Monitoring Plan (CMP) for each study. This includes all types of monitoring visits across all trial phases, which can be conducted onsite or remotely based on the CMP.

Experience and Qualifications

• Graduate in a clinical or life sciences-related field; relevant experience or qualifications in allied professions may also be considered.
• Strong time management skills, attention to detail, teamwork capability, and computer literacy.
• Preferably, at least 2-3 years of experience as a Clinical Research Associate in the clinical industry.
• Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments.