Clinical Research Coordinator

ADP; San Juan (PR); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Health Insurance Coverage

Summer Bonus

Job summary

Sapphire HR Innovations seeks a Clinical Research Coordinator to plan, direct, and coordinate clinical projects, evaluating data and managing major protocol events. You will be a vital member of the research team, ensuring study success and regulatory adherence at the site.

Responsibilities include monitoring activities for protocol compliance, screening subjects, obtaining informed consent, recording adverse events, and preparing study documentation.

Qualifications

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

Responsibilities

• Monitor study activities to ensure protocol compliance and regulatory adherence.
• Screen and enroll eligible subjects; document informed consent.
• Record adverse events and report to oversight bodies; assist audits.
• Prepare study documentation including protocols and progress reports.
• Support laboratory and administrative tasks related to the study.
• Provide back-up coverage for other study functions as needed.

Skills

Organization

Communication

Biology

Administration

Tech devices

Education

Bachelor’s in Life Science

Master’s degree

Job description

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.