What are the responsibilities and job description for the Assistant Clinical Research Coord. position at SRA Trials?
Assistant Clinical Research Coordinator
Suncoast Research Associates is a privately owned and operated research organization established in 2018. We help volunteers get involved in clinical trials which allow patients to play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Our company works with all major pharmaceutical companies and conducts studies in a myriad of therapeutic areas. We are located in Doral.
Key Responsibilities
- Assist in the coordination and support clinical trials from initiation through closeout, ensuring adherence to timelines and study goals.
- Assist in the development, review, and maintenance of study protocols, standard operating procedures (SOPs), and study-related documents.
- Serve as a liaison between study sites, investigators, sponsors, and external vendors to ensure effective communication and execution of study activities.
- Schedule and coordinate participant visits, study procedures, assessments, and data collection activities.
- Support regulatory submissions by preparing, organizing, and maintaining essential documents in compliance with applicable regulations and guidelines.
- Assist with participant recruitment, screening, enrollment, and informed consent in accordance with protocol requirements.
- Perform study-related procedures in strict compliance with approved protocols, GCP guidelines, and regulatory standards.
- Collect, manage, and accurately enter clinical study data into electronic data capture (EDC) systems.
- Conduct data quality checks, identify discrepancies, and collaborate with study teams to resolve issues promptly.
- Maintain accurate, complete, and audit-ready study records and documentation.
- Monitor study progress and ensure ongoing compliance with protocol, sponsor, and regulatory requirements.
- Coordinate and support monitoring visits, audits, and inspections.
- Identify deviations and implement corrective and preventive actions (CAPA) as needed.
- Collaborate effectively with cross-functional study teams to ensure successful study execution.
- Participate in sponsor-required training, investigator meetings, and study team calls.
- Stay current on clinical research regulations, industry guidelines, and best practices.
- Engage in ongoing professional development and training to enhance clinical research knowledge and skills.
Required Skills and Abilities
- Bachelor's degree in a relevant field preferred (e.g., life sciences, nursing, public health).
- Previous experience in clinical research or healthcare preferred.
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Strong organizational skills and attention to detail.
- Excellent communication skills in both English and Spanish and interpersonal skills.
- Ability to work effectively in a team environment.
- Proficiency in Microsoft Office and electronic data capture systems.
- Able to meet our schedule of 7 am to 4 pm.
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday