Senior Clinical Research Coordinator

Senior Clinical Research Coordinator

The Puerto Rico Consortium for Clinical Investigation (PRCCI) was formed as part of a strategy that aims to develop Puerto Rico as a clinical research hub. PRCCI is a non-for-profit organization, which is supported by the Puerto Rico Science, Technology & Research Trust (PRSTRT), a private non-for-profit organization. PRSTRT was created in 2004 to encourage and promote: innovation, transfer, and commercialization of technology & research, and foster the creation of jobs in the technology sector.

PRCCI has been impacting the quality, and speed execution of clinical research in Puerto Rico since 2016. We provide a single point of contact for sponsors with an experienced, network of high-quality research sites, providing access to a variety of patient populations, and improving speed of clinical trials through faster patient recruitment and start-up processes. All current employees get involved in various aspects of the organization and everyone is contributing to the overall success of the company.

Purpose

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.

Key Responsibilities and Duties

The Senior CRC 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. The Senior CRC is responsible for coordinating some studies and for overseeing the coordination of other studies.

• Review and become familiar with the study protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc.
• Conduct the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places.
• Assure that amended consent forms are appropriately completed and signed.
• Responsible for Data Delinquency, and completion of queries in a timely manner.
• Educate and inform the research staff and investigators on everything related to the protocol: amendments, safety reports, etc.
• Creation and implementation of recruitment strategies.
• Meet 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.
• Maintain direct communication with the PI, investigators, and clinical research coordinators (CRCs).
• Review and pre-screen new patient charts or EHR to determine if they qualify for a protocol.
• Responsible for overseeing patient eligibility to participate in the study.
• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
• Inform subjects of the imaging studies and other studies required by the protocol.
• Complete and verify the eligibility checklist.
• Verify that the informed consent has been obtained complying with Federal, Local and IRB regulations.
• Inform and provide guidance to the participant on everything related to the protocol, consent, and randomization process.
• Assist in the preparation of all documents related to the informed consent process.

Patient Enrollment/Study Conduct:

• Senior CRC is the main contact for the conduct of the trial.
• Contact protocol staff for any questions related to enrollment and randomization of participant.
• Register participants at the appropriate coordinating center.
• Confirm the eligibility checklist, assigned treatment or arm and subject identification number.
• Maintain 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. and ensure that patient information is entered into the Site's Patient Registry platform.
• Oversee coordination of patient visits (preparation for visits and visit conduct according to the protocol.

Data Collection & Biospecimens Samples:

• Senior CRC is responsible for sample collection and submission in a timely manner:
• Coordinate and participate in specimen collection, packaging and shipping as specified in the study protocol.
• Coordinate participant tests and procedures.
• Obtain and register subjects' physical data or findings, pathology information, and any other essential data for the study. Assure timely completion of Case Report Forms.
• Submit the subject's data on the time frame specified by the study.
• Maintain a log of Adverse Events and reports in a timely manner according to the regulations.

Quality Control:

• Senior CRC is responsible for keeping track of the patient cases and enrollments:
• Make sure that the research staff has all the protocol information and complies with study guidelines.
• Prepare for internal and external audits.
• Maintain quality standards to preserve the integrity of data findings.
• Establish standards for study files, including, but not limited to, regulatory binders, study specific source documentation, and other materials.

Other Tasks:

• Coordinate and assist site staff with the day-to-day operations and provide support to the clinical staff to ensure high quality, high-volume and efficient productivity.
• Collaborate with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.
• Maintain effective and positive working relationships with stakeholders (patients, sponsors, physicians, and employees).
• Troubleshoot and ensure compliance with study protocol and procedures.
• Collect and analyze data and Conduct literature reviews.
• Support site staff preparing materials for submission to granting agencies and foundations.
• Request equipment or supplies necessary for the project.
• Support the preparation of progress reports for the PI, funding agency, and stakeholders and documents for articles, reports, and presentations.
• Prepare 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.
• Manage investigation study product (IP) and applicable documentation.
• Coordinate and participate in community outreach activities that occasionally, will be outside regular business hours to complete special projects or as part of trial recruitment efforts.
• Assist in the identification of new clinical trials/projects, PIs and prepare assigned reports.

Since our organization is going to change to meet the needs of our stakeholders and to fulfil our business plan, you can expect, anticipate, and assume that your job description will change to meet these challenges.

Qualifications & Technical Job 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.

Experience & Educational Requirements