Clinical Protocol Coordinator

PriceSenz; Bethesda (MD); On-site; USD 85,000 - 110,000; Full time

Job summary

PriceSenz is seeking a qualified individual to assist researchers with protocol development and the assembly and review of clinical trial documents. The role involves coordinating multiple trials, managing data and documentation, and ensuring regulatory compliance within a NIH/NIAID context.

Required qualifications include a Master's degree (PhD preferred), extensive experience in clinical trials, and strong knowledge of GCP and patient privacy.

Qualifications

• Assists researchers with protocol development and review of clinical trial documents.
• Experience in coordinating and implementing multiple clinical trials in affiliation with NIAID/DIR program.

Responsibilities

• Provide advanced expertise in clinical trial coordination and implementation, data and protocol management.
• Assist with data collection, data reporting, and coordination of diverse clinical trials.

Skills

Clinical trial coordination

Interdisciplinary collaboration

GCP knowledge

Privacy of patient data

Infectious disease experience

Education

Master's degree

PhD

General Medical and Health Services

Tools

MS Office

Job description

Position Requirements

Overall Position Summary and Objectives

Min Education

Master's

Resume Max Pages

3

Additional Qualifications

Certifications & Licenses

- PhD is required

Field of Study

- General Medical and Health Services

Software

- MS Office

Skills

- Experience in clinical trials and have experience working in an interdisciplinary environment such as a university hospital or research hospital like the NIH CC - 5-6 years professional experience with adults Due to the nature of the clinical trials performed by the LID, the contractor must be comfortable and have experience working with individuals with infectious diseases requiring isolation - Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient's medical records - Knowledge of Good Clinical Practice (GCP)

Work Location

IC: NIAID

Street: 33 North Dr

Bldg: NIHBC 33

- C.W. Bill Young

Center

Room: 3N16A

City: Bethesda

State & Zip: MD 208

92

Work Hours

Weekly Hours

FT: 30-40 hours per week

# Of Hours

40

Statement of Work Details

Assists researchers with protocol development, assembly and review of clinical trial documents.

• Provide advanced expertise in clinical trial coordination and implementation, data and protocol management. Assist with the
• implementation, tracking, data abstraction and collection, data reporting, and coordination of a variety of clinical trials in affiliation with the NIAID/DIR program

Assists researchers develop and maintain trial related documents and operational procedures.

• Interview and screen participants for entry onto protocols

Maintains study databases and conducts basic analysis.

• Assist with clinical protocols by assembling and training the study team

Assists researchers collect, distribute and file regulatory documents.

• Coordinate the scheduling of participants

Provides technical support to researchers and the clinic.

• Oversees compliance to protocol; developing and adhering to relevant SOPs

Develops and assembles clinical trial documents.

• Provide quality-control, completion and submission of study related documentation

Develops and maintains trial related documents and operational procedures.

• Prepare and assist with submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence

Collects and distributes regulatory documents.

• Develop study budgets and track budget expenses and billing for relevant services

Develops, assembles and reviews clinical trial documents.

• Facilitate study enrolment through multiple mechanisms.

Collects, distributes and files regulatory documents.

• Ensure participant compliance to study responsibilities through systematic notification

Reviews and recommends changes to clinical trial documents.

• Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study

Reviews and maintains trial related documents and operational procedures.

• Coordinate the collection, processing, shipment and storage of biospecimens

Collects, distributes and submits regulatory documents.

• Monitor study enrolment goals and initiate strategies to promote enrolment.

Develops training plans and trains staff on the proper techniques for protocol submission.

• Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits