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Parallel18 · 1 month ago

Senior Clinical Research Coordinator (Fixed Term Contract)

Innovation Center, San Juan, PR, US

Full-time, Contract

Onsite

Senior Level

5+ years exp

Parallel18 is a non-for-profit organization that aims to develop Puerto Rico as a clinical research hub. The Senior Clinical Research Coordinator will support and coordinate daily clinical trial activities, ensuring compliance with regulations and study protocols while maintaining participant safety and data integrity.

FinanceFinancial ServicesNon ProfitVenture Capital

Responsibilities

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

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

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

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

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

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

Qualification

Clinical trials managementRegulatory complianceData managementBilingual communicationClinical research certificationProject managementCustomer service skillsTeam collaborationAttention to detailWork ethicAdaptabilityTime management

Required

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