Item desStudy Oversight & Protocol Expertise: Maintain in-depth knowledge of all active studies at the Iselin RDR site and act as the go-to resource for the clinical team, offering guidance on protocols and problem-solving.

• Team Leadership & Mentorship: Manage and support the day-to-day operations of the CRC/RA research team, promoting career growth and development. Provide hands-on mentorship, especially to junior staff.

• Project Management Support: Attend study meetings to help prioritize tasks, manage timelines, and ensure projects stay on track. Provide leadership in addressing any challenges.

• Collaborate with Key Stakeholders: Serve as the primary point of contact for investigators, medical monitors, CRAs, and clinical vendors (e.g., anesthesia, PT, psych). Ensure effective communication and timely delivery of clinical trial activities.

• Clinical Trial Management: Work closely with investigators to coordinate the planning and execution of clinical trials, from activation to closure.

• Quality Assurance & Compliance: Support quality assurance by ensuring studies adhere to protocols and standard operating procedures (SOPs). Review study documents to ensure compliance.

• Training & Onboarding: Collaborate with HR to lead the onboarding process for new clinical staff, including contract and part-time employees, with a hands-on mentorship approach. Provide bi-annual evaluations for CRCs and RAs, addressing performance issues in real time.

• SOP Development & Maintenance: Assist in the creation and continuous improvement of Standard Operating Procedures (SOPs).

• Reporting: Regularly report to the Director of Site Network Operations on team progress, study status, and operational needs

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for a clinical research coordinator who has at least 5 years experience with the conduct of clinical research to join our wonderful team of motivated research professionals. Ideally, the right candidate has prior clinical research experience conducting investigational clinical trials and is already familiar with clinical research workflows, regulatory requirements, and data collection and documentation practices.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Assists Principal Investigator (PI) in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.

• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.

• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

• Collects documents needed to initiate the study and submit to the sponsor (e.g., Form FDA 1572, CVs, etc.).

• Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.

• Conducts or participates in 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 implemented and signed.

• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

• Performs safety and efficacy assessments per study protocol.

• Collect or coordinate collection of clinical procedures such as vital signs, ECGs, blood draws, IP infusions.

• Responsible for timely data entry and query resolutions.

• Reports study findings, such as serious adverse events (SAEs) or protocol deviations (PDs) to the applicable department, such as the sponsor or IRB.

• Manages participant chart binders and coordinates accurate completion of source with various delegated staff.

• Follows participants from the start to end of study participation and escalates safety concerns to appropriate individuals, such as the PI or Medical Monitor.

• Prepare study data for interim monitoring visits and meet with study monitor to follow-up on resolving queries/issues.

• Communicate with sponsors, CROs, vendors, or other representatives promptly and professionally.

• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

• Updates source documents per study protocol amendment.

• Coordinate operations with other departments to facilitate completion of procedures during participant visits, includes communications with nurse practitioners, medical assistants, pharmacy, regulatory, and/or physical therapy.

• Retains all study records in accordance with sponsor requirements.

• Works with the PI and study-specific RAs to manage the day to day activities of the study including problem solving, communication, and protocol management.

• Ability to exercise independent judgment and discretion

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• BA/BS in a life sciences or related field required.

• 5 years previous CRC experience at a clinical trial site

• 2 years experience training/developing RAs and other CRCs

• Must have GCP, IATA, ALCOAC training

• BLS/CPR training upon hire date

Job Type: Full-time

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for a clinical research coordinator who has at least 5 years experience with the conduct of clinical research to join our wonderful team of motivated research professionals. Ideally, the right candidate has prior clinical research experience conducting investigational clinical trials and is already familiar with clinical research workflows, regulatory requirements, and data collection and documentation practices.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Assists Principal Investigator (PI) in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.

• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.

• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

• Collects documents needed to initiate the study and submit to the sponsor (e.g., Form FDA 1572, CVs, etc.).

• Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.

• Conducts or participates in 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 implemented and signed.

• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

• Performs safety and efficacy assessments per study protocol.

• Collect or coordinate collection of clinical procedures such as vital signs, ECGs, blood draws, IP infusions.

• Responsible for timely data entry and query resolutions.

• Reports study findings, such as serious adverse events (SAEs) or protocol deviations (PDs) to the applicable department, such as the sponsor or IRB.

• Manages participant chart binders and coordinates accurate completion of source with various delegated staff.

• Follows participants from the start to end of study participation and escalates safety concerns to appropriate individuals, such as the PI or Medical Monitor.

• Prepare study data for interim monitoring visits and meet with study monitor to follow-up on resolving queries/issues.

• Communicate with sponsors, CROs, vendors, or other representatives promptly and professionally.

• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

• Updates source documents per study protocol amendment.

• Coordinate operations with other departments to facilitate completion of procedures during participant visits, includes communications with nurse practitioners, medical assistants, pharmacy, regulatory, and/or physical therapy.

• Retains all study records in accordance with sponsor requirements.

• Works with the PI and study-specific RAs to manage the day to day activities of the study including problem solving, communication, and protocol management.

• Ability to exercise independent judgment and discretion

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• BA/BS in a life sciences or related field required.

• 5 years previous CRC experience at a clinical trial site

• 2 years experience training/developing RAs and other CRCs

• Must have GCP, IATA, ALCOAC training

• BLS/CPR training upon hire date

Job Type: Full-time