Clinical Research Associate

Placements24; United States; Hybride; USD 35 000 - 53 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Medical and retirement benefits

Bonus structure

Professional development opportunities

Hybrid work arrangement

Résumé du poste

Placements24 is seeking a dedicated Clinical Research Associate to strengthen the clinical operations team. The role, based in a hybrid setting in Gauteng, ZA, involves ensuring trial protocols and regulatory compliance, data integrity, and effective coordination with site staff and investigators.

Ideal candidates bring 3+ years of CRA experience, strong GCP/ICH knowledge, and the ability to travel up to 40%. Join a team focused on advancing new therapies and maintaining rigorous trial standards.

Qualifications

• Bachelor's degree as required in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum of 3 years in a Clinical Research Associate or similar role.
• Strong understanding of GCP, ICH guidelines, and local regulatory requirements.
• Proven experience in site monitoring, data review, and regulatory document management.

Responsabilités

• Monitor clinical trial sites to ensure adherence to protocol, GCP, and regulatory requirements.
• Verify accuracy, completeness, and integrity of clinical data collected at study sites.
• Manage site initiation, interim monitoring visits, and close-out activities.
• Act as primary point of contact for study sites and address queries or issues.
• Prepare and submit essential regulatory documents and reports.
• Oversee drug accountability and investigational product management at sites.
• Maintain TMF documentation.
• Collaborate with investigators, site staff, and internal project teams to progress trials.

Connaissances

GCP & ICH knowledge

CTMS proficiency

EDC proficiency

Site monitoring

Data review

Regulatory document management

Communication & teamwork

Travel readiness 30-40%

Formation

Bachelor's degree in Life Sciences/Nursing/Pharmacy or related field

Outils

CTMS

EDC

Description du poste

About the Role

Our client is a prominent pharmaceutical company actively seeking a dedicated Clinical Research Associate to bolster their clinical operations team. This role is based in Tembisa, Gauteng, ZA , and offers a hybrid work model, blending office-based responsibilities with the flexibility of remote work. You will play a pivotal role in ensuring the successful execution of clinical trials, adhering strictly to protocols and regulatory standards. The ideal candidate is meticulous, organized, and possesses a deep understanding of clinical trial processes. This position is ideal for an individual who thrives in a structured yet adaptable environment and is keen to contribute to the advancement of new therapies. You will be part of a dedicated team committed to bringing life-changing medications to patients.

Key Responsibilities

• Monitor clinical trial sites to ensure adherence to protocol, GCP, and regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
• Manage site initiation, interim monitoring visits, and close-out activities.
• Act as the primary point of contact for study sites, addressing any queries or issues that arise.
• Prepare and submit essential regulatory documents and reports.
• Oversee drug accountability and investigational product management at sites.
• Ensure all study-related documentation is maintained in the Trial Master File (TMF).
• Collaborate with investigators, site staff, and internal project teams to facilitate trial progress.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
• Thorough understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.
• Proven experience in site monitoring, data review, and regulatory document management.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel to clinical trial sites as required (approximately 30-40%).
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Must reside within commuting distance of Tembisa, Gauteng, ZA for hybrid work requirements.

Benefits

• We offer a competitive salary, comprehensive medical and retirement benefits, and a performance-based bonus structure.
• Professional development opportunities, including training and conference attendance, are provided.
• The hybrid work arrangement promotes a healthy work-life balance.
• Our client values employee well-being and fosters a supportive and collaborative work environment.
• Opportunities for career growth within clinical operations are significant.