Clinical Research Coordinator

Coastal Pediatric Associates is hiring a Clinical Research Coordinator for our West Ashley location! We are looking for a dedicated and experienced individual to join our team and drive innovative research projects.

If you enjoy and respect children from newborns to teens and the in-betweens, you’ll love being a part of the CPA team. Join us at the Coast!

Essential Duties and Responsibilities : (includes but is not limited to) :

• Serves as study coordinator in Coastal Pediatric Research. Obtains informed consent, screens and enrolls study participants, conducts study visits as per protocol, coordinates participant visits, provides education to participants, monitors adverse events and prepares serious adverse event reports, collects and processes lab samples, enters data and completes case report forms, and maintains all study documents.
• Maintains all trial files, including source documents. Responsible for ensuring study documents are complete, organized, and readily available for audits;

Ensures study participants complete all protocol requirements within designated timeframes; Ensures study data is accurate and timely.

Coordinates study activities daily with all necessary study personnel. Prioritizes patient safety. Practices full disclosure.

Educates personnel on protocol changes. Provides additional education, training, and follow-up to personnel and participant / caregiver where necessary and appropriate.

• Data entry, routine and complete data management tracking, and general administrative support for the research team. Enters data into designated electronic data capture systems within 48 hours and answers data queries as applicable.
• Interacts with patients, site personnel, Principal Investigators, and Sub-Investigators across all Coastal Pediatric Research sites, thereby requiring effective communication skills (both written and verbal).

Works with and assists the clinical research team in conducting studies in accordance with all federal, state, and CPA requirements, regulations and policies.

Assists in the communication of appropriate information to patients, legal guardians, sponsors, physicians and other individuals.

Identifies target populations and develops tools to raise awareness to recruit study-eligible patients. Provides participants with information and education with regard to appropriate studies.

Uses internal patient databases as professionally appropriate. Works directly with PI and Sub-I’s to determine participant eligibility based on inclusion / exclusion criteria for each study.

• Creates new databases and maintains existing databases not limited to training, temperatures, and equipment calibration logs.
• Collects (as applicable) and performs specimen processing according to protocols. These include phlebotomy, urine collection, and processing specimens.

Maintains inventory control of all samples and lab kits. Ensures proper preparation and shipment of samples. Maintains certifications in proper testing and collection techniques.

Ensures lack of contamination through sterile techniques.

Responsible for proper regulatory maintenance of trial master file and IRB correspondence including continuing reviews, modifications for IRB applications and other regulatory documents as needed.

Ensures all personnel have proper certifications and trainings. Responsible for timely and accurate IRB applications, and responsiveness.

Participates in all study-related conference calls and research group meetings. Provides back-up coverage for the 24-hour research contact line and triages to the appropriate staff member.

Performs special projects for the Financial & Regulatory Manager, Director of Clinical Research, and Senior Leadership as needed.

• Organizes, plans, and manages time effectively
• Completes all mandatory training as required
• Attends staff meetings as required

Requirements

• High school diploma or equivalent.
• Two years of relevant clinical trial experience. A bachelor’s degree may be substituted for the required clinical trial experience.
• Prior medical practice experience is preferred.
• Good communication and organizational skills with a high level of professionalism at all times
• Maintains all appropriate certifications for clinical research, including lab and specimen collection
• Ability to multitask and strong attention to detail
• Intermediate Microsoft Office skills
• Ability to plan and manage multiple priorities under high pressure situations with tight deadlines
• Excellent written and oral communication and interpersonal skills
• Strong problem solving capabilities
• Ability to work proactively and independently and in an efficient and effective manner
• Collaborative work style, team player, and strong work ethic
• Working knowledge of computer applications. Prior experience with EMR preferred.
• Ability to speak, read and write effectively.
• Ability to work independently without direct supervision.
• Ability to coordinate, analyze, observe, make decisions, and meet deadlines, in a detail-oriented manner.
• Ability to work weekdays, evenings, and weekends.
2 days ago