Senior Clinical Research Coordinator

Puerto Rico Science Technology & Research Trust•San Juan, PR

2d•Onsite

About The Position

The Senior Clinical Research Coordinator (CRC) is a resourceful, detail oriented, and collaborative team member with excellent people management skills. The primary role of this position is to support, facilitate and coordinate the daily clinical trial activities and play a critical role in the study conduct ensuring that the study meets its intended goals and that the local team conducts the clinical trial in compliance with all local, federal and global regulations. The Senior CRC communicates with the study stakeholders for the successful implementation of the clinical trial. The ideal candidate will play a key role in managing clinical trials across multiple therapeutic areas and multiple sites, ensuring compliance with regulatory requirements and study protocols while maintaining the highest standards of participant safety and data integrity. The position requires regular travel to study sites, making it essential for the candidate to be adaptable and organized.

Requirements

Excellent written and verbal communication skills in English and Spanish.
Outstanding customer service and diplomacy skills when interacting with clients and participants.
Ability to collaborate with team members in a dynamic and fast-paced work environment.
Manages time effectively by prioritizing tasks, managing competing priorities.
Attention to detail and project management skills.
Ability to apply new skills and concepts quickly and displays a willingness to learn and transfer knowledge to team members.
Superior working knowledge of office applications and online collaboration tools, such as Microsoft Suite, Google products, SharePoint, One Drive, Adobe PDF, DocuSign, Teams, etc.
Ability to learn and use sponsor and company-specific software.
A strong work ethic, ability to maintain and model high personal, ethical, and professional standards, as well as an outgoing and positive personality.
Able to work outside regular business hours, occasionally, to manage special projects and reports or to attend company events.
Master’s degree in a health-related field or relevant
A minimum of five years of experience in clinical trials research setting as a data manager CRA/CRC or other similar role.

Nice To Haves

Certification in clinical research (e.g., ACRP or SOCRA, PRCCI) preferred.

Responsibilities

Oversees and manages CRCs in daily activities including but not limited to, assisting study start-up; recruiting, enrolling, and retaining participants in the study; performing study assessments and follow-ups; data entry and management; and facilitating community outreach and stakeholder engagement activities.
Coordinates some studies and oversees the coordination of other studies.
Reviews and becomes familiar with the study protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc.
Conducts the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study.
Obtains appropriate signatures and dates on forms in appropriate places.
Assures that amended consent forms are appropriately completed and signed.
Responsible for Data Delinquency, and completion of queries in a timely manner.
Educates and informs the research staff and investigators on everything related to the protocol: amendments, safety reports, etc.
Creation and implementation of recruitment strategies.
Meets periodically with PI and sponsor’s staff (e.g., Clinical Research Associates) to discuss progress and for site visits.
Responsible for patient recruitment and Retention for assigned studies.
Maintains direct communication with the PI, investigators, and clinical research coordinators (CRCs).
Reviews and pre-screens new patient charts or EHR to determine if they qualify for a protocol.
Responsible for overseeing patient eligibility to participate in the study.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
Informs subjects of the imaging studies and other studies required by the protocol.
Completes and verifies the eligibility checklist.
Verifies that the informed consent has been obtained complying with Federal, Local and IRB regulations.
Informs and provides guidance to the participant on everything related to the protocol, consent, and randomization process.
Assists in the preparation of all documents related to the informed consent process.
Is the main contact for the conduct of the trial.
Contacts protocol staff for any questions related to enrollment and randomization of participant.
Registers participants at the appropriate coordinating center.
Confirms the eligibility checklist, assigned treatment or arm and subject identification number.
Maintains a master list for all the enrolled patients. This list should have subject name, subject id, randomization date, investigator name. This list must be updated every other week.
Ensures that patient information is entered into the Site’s Patient Registry platform.
Oversees coordination of patient visits (preparation for visits and visit conduct according to the protocol.
Is responsible for sample collection and submission in a timely manner.
Coordinates and participates in specimen collection, packaging and shipping as specified in the study protocol.
Coordinates participant tests and procedures.
Obtains and registers subjects’ physical data or findings, pathology information, and any other essential data for the study.
Assures timely completion of Case Report Forms.
Submits the subject’s data on the time frame specified by the study.
Maintains a log of Adverse Events and reports in a timely manner according to the regulations.
Is responsible for keeping track of the patient cases and enrollments.
Makes sure that the research staff has all the protocol information and complies with study guidelines.
Prepares for internal and external audits.
Maintains quality standards to preserve the integrity of data findings.
Establishes standards for study files, including, but not limited to, regulatory binders, study specific source documentation, and other materials.
Coordinates and assists site staff with the day-to-day operations and provides support to the clinical staff to ensure high quality, high-volume and efficient productivity.
Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.
Maintains effective and positive working relationships with stakeholders (patients, sponsors, physicians, and employees).
Troubleshoots and ensures compliance with study protocol and procedures.
Collects and analyzes data and conducts literature reviews.
Supports site staff preparing materials for submission to granting agencies and foundations.
Requests equipment or supplies necessary for the project.
Supports the preparation of progress reports for the PI, funding agency, and stakeholders and documents for articles, reports, and presentations.
Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document case report forms (CRF’s), enrollment logs, and drug/device accountability logs.
Manages investigation study product (IP) and applicable documentation.
Coordinates and participates in community outreach activities that occasionally, will be outside regular business hours to complete special projects or as part of trial recruitment efforts.
Assists in the identification of new clinical trials/projects, PIs and prepares assigned reports.
Anticipates and assumes that job description will change to meet the needs of stakeholders and to fulfill the business plan.