Site Development & Integration Coordinator

DM Clinical Research; Houston (TX); On-site; USD 45,000 - 60,000; Full time

Job summary

A clinical research organization in Houston is looking for a Site Development & Integration Coordinator to oversee the quality of research at investigative sites. The role involves conducting training, managing documentation, and liaising between teams. Candidates should have a High School Diploma and relevant experience in clinical research, preferably as a CRC. Bilingual in Spanish and flexibility for travel is preferred. This position offers opportunities for growth and contribution to impactful research.

Qualifications

• At least one year of experience as a CRC, preferably with industry-sponsored vaccines in a private setting.
• Minimum two years of experience in a clinical research setting as a research assistant or equivalent.

Responsibilities

• Ensure quality research is conducted at assigned sites according to protocols.
• Conduct study subject visits and document procedures.
• Participate in subject recruitment and retention efforts.

Skills

Detail-oriented

Bilingual in Spanish

Energy and motivation

Multi-tasking ability

Education

High School Diploma or equivalent

Foreign Medical Graduates

Tools

EDC systems

Laboratory equipment

Job description

Location: Houston, TX

Job Id:1110

# of Openings:2

The Site Development & Integration Coordinator will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor.

DUTIES & RESPONSIBILITIES

• Completing all the relevant training prior to study-start and on a continued basis in a timely manner
• Complete and implement Sponsor-provided and IRB-approved Protocol Training
• All relevant Protocol Amendments Training or study-specific manual trainings
• Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training
• Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner
• Adherence to ALCOA-C Standards with all the relevant clinical trial documentation
• Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations
• Demonstration of appropriate and timely follow-up on the action items, at their respective sites
• Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols
• Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols
• Submitting required administrative paperwork per company timelines
• Participating in subject recruitment and retention efforts
• Engaging with Research Participants and understanding their concerns
• Complete data reviews to ensure the highest standards of data integrity
• Conduct training for site and SDI personnel
• Any other matters, as assigned by management

KNOWLEDGE & EXPERIENCE

Education:

• High School Diploma or equivalent required
• Foreign Medical Graduates preferred

Experience:

• At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
• At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting

Credentials:

• ACRP or equivalent certification is preferred
• Registered Medical Assistant certification or equivalent is preferred
• DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification
• Knowledge and Skills:
• Be an energetic, go-getter who is detail-oriented and can multi-task.
• Be goals-driven while continuously maintaining quality.
• Bilingual in Spanish is preferred
• Flexibility with scheduling, including travel (50%) when required