Clinical Research Coordinator

Sapphire HR Innovations - PR; San Juan (PR); Presencial; USD 42.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance coverage

Summer bonus

Weekday schedule

Descripción de la vacante

Sapphire HR Innovations - PR is seeking a Clinical Research Coordinator to plan, direct, and coordinate clinical research projects. You will evaluate data and carry out major protocol events as an integral member of the team.

The role requires organization, strong communication, and knowledge of medical terminology. Fluent English and Spanish are essential, with a Monday–Friday schedule and opportunities for professional growth.

Formación

• Bachelor’s degree in a life science or related field required; Master’s degree preferred.
• 3 to 5 years of related experience required.

Responsabilidades

• Coordinate clinical research projects and ensure protocol events are carried out.
• Monitor study activities for protocol compliance and regulatory requirements.
• Record adverse events and assist with quality assurance audits.
• Identify protocol problems and assist in resolution or revisions.
• Prepare study-related documentation and progress reports.
• Instruct staff on study procedures, consent, and documentation.

Conocimientos

Organization

Communication

Biology terminology

Admin & Mgmt

Tech devices

Bilingual English/Spanish

Educación

Bachelor’s degree in life sciences

Master’s degree preferred

Descripción del empleo

The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate and analyze clinical data. The main duty is to carry out major experimental protocol events. The clinical research coordinator plays a vital role in ensuring the success of our research projects and is an integral member of the team.

Duties/Responsibilities:

• Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory and institutional polices. Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• May be involved in research using clinical trials, human subjects, or a variety of other methods.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, and progress reports.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Instructs other staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• May order and receives drugs or devices necessary for study completion.
• Supervises the care provided to patients and users.
• Verifies and audits the patients’ medical file and processes missing information or signatures.
• Completes special projects like surveys, statistical reports, studies, and research. Contributes to the general center functions and institutional needs. Performs specimen collection and processing duties according to policies established in the medical specialty area.
• Support with technological equipment related to study.
• Support with administrative equipment related to study (compensation or other).
• Serve as back-up for laboratory and other functions as needed.
• Other responsibilities and duties assigned by the Administrator or Clinic Director.

Required Skills/Abilities:

• Highly organized and detail-oriented
• Excellent communication and interpersonal skills
• Knowledge of biological and medical terminology.
• Understanding of the principles of administration and management.
• Use of technological equipment, e-pro tablets and other technical devices to support study.
• Proficiency in Spanish and English language.

Education and Experience:

• Bachelor’s degree in a life science or related field required. Master’s degree preferred.
• 3 to 5 years of related experience required.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer and standing in a lab.
• Must be able to lift up to 15 pounds at times.

Compensation and Benefits:

• 100% Health Insurance Coverage
• Summer Bonus (Based on Productivity)
• Monday thru Friday 7:00am - 4:00pm

Sapphire HR Innovations is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other protected characteristic under applicable law.