Clinical Research Coordinator

PhaseWell Research; San Juan (PR); Vor Ort; USD 28.000 - 32.000; Vollzeit

Benefits dieser Stelle

100% employer-paid health insurance

Zusammenfassung

PhaseWell Research is seeking an experienced bilingual Clinical Research Coordinator to lead our clinical studies from start to finish. You will coordinate day-to-day study operations, safeguard participant safety and data integrity, and keep protocols on track.

You will recruit and enroll participants, oversee informed consent, monitor safety, and manage study documentation. The role requires Spanish/English fluency, strong organizational skills, and experience with study technology.

Qualifikationen

• Bachelor’s degree in life sciences or related field.
• 3–5 years in clinical research or related experience.
• Fluency in Spanish and English.
• Strong knowledge of biological and medical terminology.
• Excellent organizational and attention to detail.
• Excellent communication and interpersonal skills.
• Solid understanding of administrative and management principles.
• Comfort using study technology, including ePRO tablets and other electronic devices.

Aufgaben

• Lead study execution: plan, coordinate, and evaluate clinical research projects.
• Ensure protocol compliance with regulations and policies.
• Screen and enroll participants with informed consent oversight.
• Monitor participant care and enrollment status at study visits.
• Record adverse events and report to investigators and oversight bodies.
• Maintain study records, CRFs, drug dispensation, and regulatory docs.
• Prepare study materials, reports, and progress updates.
• Review and revise protocols for data management and risks.

Kenntnisse

Bilingual Spanish/English

Organizational skills

Communication skills

Interpersonal skills

Ausbildung

Bachelor’s degree in life sciences

Master’s degree preferred

Tools

ePRO tablets

EDC systems

Jobbeschreibung

About The Role

We are looking for an experienced, bilingual Clinical Research Coordinator to help lead our clinical studies from start to finish. In this role, you will coordinate day-to-day study operations, safeguard participant safety and data integrity, and keep every protocol on track. You will be a central part of the team that makes our research succeed.

About The Role

We are looking for an experienced, bilingual Clinical Research Coordinator to help lead our clinical studies from start to finish. In this role, you will coordinate day-to-day study operations, safeguard participant safety and data integrity, and keep every protocol on track. You will be a central part of the team that makes our research succeed.

What You Will Do

• Lead study execution: Plan and coordinate clinical research projects, carry out key protocol events, and evaluate and analyze clinical data.
• Ensure compliance: Monitor study activities for compliance with protocols, institutional policies, and local, state, and federal regulations.
• Recruit and enroll participants: Screen potential participants through interviews, medical record reviews, and discussions with physicians and nurses, and oversee enrollment to ensure informed consent is properly obtained and documented.
• Support participants: Oversee participant care during study visits, track enrollment status, and document withdrawals, including reasons and contact efforts.
• Monitor safety: Record adverse events and side effects, and work with investigators to report them to the appropriate oversight agencies.
• Manage documentation: Maintain accurate study records, including case report forms, drug dispensation logs, and regulatory documents. Audit participant files and resolve missing information or signatures.
• Prepare study materials: Prepare protocol worksheets, procedure manuals, adverse event reports, and progress reports.
• Review and improve protocols: Review proposed protocols for sample collection, data management, and participant risk. Identify protocol issues, alert investigators, and help resolve them, including through protocol revisions.
• Support audits: Prepare for and participate in quality assurance audits by sponsors, federal agencies, and designated review groups.
• Train the team: Train staff on the scientific and procedural aspects of studies, including standards of care, informed consent, and documentation.
• Handle specimens and lab support: Collect and process specimens according to established policies, and serve as backup for laboratory and other functions as needed.
• Coordinate supplies and logistics: Order and receive study drugs and devices as needed, support study technology and equipment, and manage administrative items such as participant compensation.
• Contribute beyond the study: Complete special projects such as surveys, statistical reports, and research studies, contribute to broader center needs, and take on other duties assigned by the Administrator or Clinic Director.

What You Bring

• Bachelor’s degree in life sciences or a related field (master’s degree preferred)
• 3 to 5 years of clinical research or related experience
• Fluency in Spanish and English
• Strong knowledge of biological and medical terminology
• Exceptional organization and attention to detail
• Excellent communication and interpersonal skills
• Solid understanding of administrative and management principles
• Comfort using study technology, including ePRO tablets and other electronic devices

Physical Requirements

• Ability to sit for extended periods at a desk and computer, and to stand for extended periods in a laboratory
• Ability to occasionally lift up to 15 pounds

Compensation, Benefits, And Schedule

Pay:

$20.00 - $23.00/ hour

Benefits:

100% employer-paid health insurance

Schedule:

Monday through Friday, 7:00 a.m. to 4:00 p.m.C