Clinical Research Office-Research Study Coordinator

  • Full Time
  • Ponce

Ponce Health Sciences University (PHSU)/Ponce Research Institute (PRI) is seeking a Clinical Research Coordinator to assist with the daily studies coordination of the Clinical Research Office (CRO).

PHSU is a private, bilingual center of higher education located in the southern coastal city of Ponce in Puerto Rico. PHSU has a dynamic research program that is currently undergoing a period of aggressive growth with the newly developed Ponce Research Institute, state of the art laboratories, and a well-established Ph.D. Program in Biomedical Sciences. The Institution currently receives ~$7 million per year in NIH research funds. We have a state-of-the-art Biomedical Animal Resource Facility, a Behavioral Neuroscience Core Facility, a Clinical Research Division, and a Molecular Core Facility.

Experience and Education

Qualifications Bachelor’s degree in related field and three (2) years research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research.

Licenses & Certifications: CCRP/CCRC certification through SOCRA /ACRP, preferred

Job Duties

Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.

Coordinates all regulatory aspects, completion of data forms, preparing safety reports, adverse events, FDA compliance, drug company monitoring visits, laboratory standards; and; maintains databases related to these regulatory aspects.

Coordinates aggregation and maintenance of local and national research data required to ascertain and identify research study outcomes; oversees and perform entry of research data into the assign data capture systems.

Develops and prepares statistical research reports, charts, and graphs as required during research studies.

Assists with regulatory compliance including assisting with preparing IRB materials for approval of protocol amendments, submitting Investigational New Drug (IND) Safety

Learns knowledge of departmental functions through reading literature, attending workshops, seminars and conferences, and by participating in professional organizations

Learns to conduct audits of research studies to check the accuracy, integrity and consistency of research studies

Assists in design of research survey forms to capture required participant information; consent research subjects, interviews research study subjects and/or family members to gather research study information.

Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper informed consent; tracks subjects’ information from multiple projects. Prepares informed consent forms for subjects’ families.

Coordinates collection and data management of research studies from multiple projects by interacting with internal and external research data managers, patients, investigators, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects.

Serves as primary liaison and prepares annual reports for federal, state, corporate and/or local agencies. Informs Institutional Review Board of amendments, continue reviews and modifications to research studies; prepares protocols and detailed summaries in lay terms of any new research study and coordinate with other departments such as pharmacy, phlebotomists, lab, and registration personnel as detail in protocols.

Essential Duties

  • Collects, verifies, organizes, completes and records clinical information and data in case report forms. Performs the following data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, resolve queries and safety coding. Assists with subject follow-up for clinical protocols and documents/report clinical study progress to assigned study team. Obtains all reports and submits data forms according to protocol requirements. Conducts protocol administration quality control monitoring, enforcement and database maintenance.
  • Provides data management project leadership to support multi-disciplinary clinical trials, including patient screening for study eligibility, obtaining Informed consent and subject registration. Handles and labels samples and ships samples according to protocol requirements.
  • Track study/clinical trials progress and issues periodic status reports. Communicates the achievement of key milestones such as draft or final database to the project team.
  • Prepares annual reports and statistical information on all clinical research as required by System, IRB or investigators.
  • Acts as liaison in support of pharmaceutical and investigator-initiated clinical protocols. May participate in site initiation, interim monitoring, and study close-out visits with sponsor and FDA initiated audits as needed. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing of clinical protocols. Represents data management at business development related meetings. May assist in the creation of business development proposals by supplying data management related information and costs.
  • Aids as needed to peers to ensure that study deadline is met. Identifies data management project issues and alerts senior department management with a view to recommendations. Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Participates in mentoring and training of staff on data management procedures, and systems, including the mentoring of all direct reports. Performs other related duties as assigned.
  • Able to perform height and weight measurements, vital signs, phlebotomy, ECG and carry out laboratory procedures

Duties performed may include one or more of the following core functions: (a) Directly interacting with or caring for patients; (b) Directly interacting with or caring for human-subjects research participants; (c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or (d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.(e) assist investigator in all areas of the research studies. **Other Duties: Performs other duties as assigned.

Please email resume to:

Roberto Torres, DHA Director, Clinical Research Office Ponce Medical School Foundation, Inc

Ponce Research Institute

E-mail: rtorres@psm.edu

The Ponce Health Sciences University is an Equal Opportunity/Affirmative Action Employer. Women and minorities are encouraged to apply.

To apply for this job email your details to rtorres@psm.edu