Clinical Trials & Business Development Supervisor

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

7h•Onsite

About The Position

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. The goal of PRCCI is to promote and enhance clinical research and development for the benefit of patients, the Puerto Rican economy and global scientific innovation. PRCCI aims to improve the impact, quality, and speed of clinical research in Puerto Rico. PRCCI provides a single point of contact connecting sponsors with an experienced, cooperative 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. The Clinical Trials & Business Development Supervisor is a resourceful, detail oriented, and collaborative team member with excellent client and people management skills. Their primary role is to support PRCCI’s business development activities as supervisor of the PRCCI Clinical Research Coordinators and Study search team. Facilitates and coordinates the daily clinical trial activities and play a critical role in identification of new studies and projects to continue building capacity to implement clinical trials at PRCCI and consortium sites. Ensures that the new trials meet their intended goals and that the study is a good match for the PRCCI team of investigators. Presents the new study protocols to potential investigators. Is the primary contact for CROs and Sponsors. Responsible for assuming the role of Clinical Research Coordinator (CRC) based on business needs.

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 work collaboratively with team members in a dynamic and fast-paced work environment.
Manages time effectively by prioritizing tasks, managing competing priorities.
Apply new skills and concepts quickly and display a willingness to learn and improve.
Superior working knowledge of office applications and online collaboration tools, such as Microsoft Suite, Google products, SharePoint, One Drive, Dropbox, Adobe PDF, Docusign, Zoom, etc.
Ability to learn and use 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.
Advanced degree in life sciences.
Healthcare professional, preferred.
A minimum of five years’ experience in a clinical trial setting as Lead Clinical Research Coordinator or another relevant role.
Formal training/certification in Clinical Research Coordination/GCP required.

Nice To Haves

Occasionally required to work outside regular business hours to complete special projects and reports or to attend company events.

Responsibilities

Develops a thorough understanding of the Industry Pipeline managing the research and identification of new clinical trial opportunities based on PRCCI’s Therapeutic Area priorities.
Search for small, mid-size and big pharmaceutical companies that have clinical trials on their pipeline and coordinate site visits and/or introductory meetings. This includes company e-mails, LinkedIn contacts and/or referrals from current contacts.
Work closely with other team members to ensure that the studies identified for the PIs are a good match with their interests and the diseases of highest prevalence in Puerto Rico (PR), focusing on the PRCCI Clinical Research Center.
Once the trials are identified, contacts sponsor to determine potential opportunities for implementation or vice versa.
Facilitates, schedules, and attends business conferences and trainings in PR/US.
Reviews and develop a deep understanding of the study protocol, including study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
Provides key elements required by the protocol to the appropriate team members (e.g., required imaging and/or laboratory vendors needed). Ensures compliance with study protocol and procedures.
Knows all aspects for the appropriate execution of clinical research studies at PRCCI. Maintains direct communication with the PI, Investigators, and coordinators.
Coordinates with vendors the participants’ appointments as necessary for the study schedule of activities.
Manages and completes feasibility questionnaires with support of the PI and PRCCI staff for new study opportunities. Supports the completion of the specific documents for each clinical research protocol.
Assist in preparation of all documents related to the informed consent process and other regulatory submissions. Maintains patients’ paper based or electronic documentation records.
Establish and organize study files, including, but not limited to, regulatory binders, study specific source documentation and other materials.
Educates and informs the PRCCI Clinical Research Center staff and investigators on everything related to the protocol amendments, safety reports, among others.
Responsible for resolving Data Queries and/or Data Delinquency issues, in the site established timelines.
Supports monitoring visits or audits, including but not limited to, Sponsor or FDA audits.
Prepares study materials, as requested by the PI. These include, but are not limited to, the informed consents, document case report forms (CRF’s), enrollment logs, drug/device accountability logs and other documentation.
Supports the preparation of progress reports for the PI, funding agency and stakeholders.
Identifies and coordinate pre-screening of possible participants for each protocol, including the review of new patient charts or EHR to determine if they qualify for a protocol.
Conducts or participates in the informed consent process. Includes interactions with the IRB, discussions with research participants, and answering any questions related to the study. Obtain appropriate signatures and dates in forms following SOPs.
Assures amended consent forms are appropriately implemented and signed.
Supports the PI and PRCCI Clinical Research Center management personnel on the creation and implementation of recruitment strategies.
Confirm the eligibility checklist, assigned treatment or arm and subject identification number.
Assists PIs in the determination of patient eligibility to participate in the study and screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
Engages participants in the informed consent process according to approved process.
May consent participants and verify that the informed consent has been obtained complying with PRCCI Clinical Research Center SOPs, and Federal, Local and IRB regulations.
Informs and provides guidance to the participants related to the protocol, consent, randomization process and study procedures and visits.
Maintains a master list for all the enrolled patients. This list should have subjects id, randomization date, investigator name. This list must be updated every other week.
Coordinates participant tests and procedures.
Responsible for data management and submission in a timely manner.
Coordinates and participates in specimen collection, processing, packaging and shipping, as specified in the study protocol.
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.
Request equipment or supplies necessary for the studies and maintain accurate inventories that enable study continuity.
In partnership with other team members, prepare presentations including epidemiological data available for the highest prevalence diseases in Puerto Rico to present the study protocols identified to our investigators. Also, prepare presentations of new studies and present the leading opportunities to potential investigators.
Presents and shares promotional materials on PRCCI Clinical Research Center and the Consortium members, promoting PRCCI with the aim to build more contacts and bring more studies to PR.
Develops and maintains existing and new relationships and/or partnerships with internal and external PRCCI departments and stakeholders, including but not limited to, Sponsors, CROs, Patients and others.
Supervise, mentors and coaches new study search support staff.
Prepare metric reports and presentations on study search efforts for business meetings.
Follows up on any pending matter necessary to proceed with the study feasibility as well as budget and contract negotiation.
Communicates appropriate information to the research staff ensuring compliance with applicable regulations.
Assists other PRCCI Clinical Research Center personnel to complete assigned tasks as necessary.
Supports the PRCCI Clinical Research Center management personnel in preparing materials for submission to granting agencies and foundations.
Any other tasks related to this role assigned by supervisor.