Clinical Research Coordinator

Rare Disease Research, LLC; Atlanta (GA); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Health insurance

Paid time off

Vision insurance

Job summary

Rare Disease Research is seeking a Clinical Research Coordinator to support ongoing studies at our Atlanta site. The role involves coordinating visits, maintaining study documentation, and ensuring compliance with GCP and IRB requirements.

You will work closely with the Principal Investigator and study team, manage data entry, recruit participants, and participate in safety assessments. A minimum of two years in clinical research is required, with CRC experience preferred.

Qualifications

• Requires 2+ years in clinical research and prior CRC experience preferred.
• Must have GCP, IATA, ALCOAC training or equivalent.
• Willingness to work on-site at the Atlanta location.

Responsibilities

• Assists PI in protecting the rights and welfare of participants per federal regs and policies.
• Maintains study training documentation and materials.
• Collaborates with PI to address audits and implement recommendations.
• Reviews protocol details, timelines, inclusion/exclusion criteria, and privacy protections.
• Collects documents to initiate studies (e.g., FDA forms, CVs).
• Develops and executes recruitment strategies under HRPO/IRB approvals.
• Supports informed consent processes and ensures proper signatures and amendments.
• Screens subjects for eligibility and documents outcomes.
• Performs safety and efficacy assessments per protocol.
• Coordinates collection of vital signs, ECGs, blood draws, IP infusions.
• Ensures timely data entry and resolves data queries.
• Reports SAEs or protocol deviations to sponsor/IRB as required.
• Maintains source documentation and study binders with delegated staff.
• Monitors participants from start to end, escalating safety concerns as needed.
• Prepares data for interim visits and coordinates monitoring follow-ups.
• Communicates with sponsors, CROs, vendors promptly and professionally.
• Completes study documentation and maintains files per sponsor and university policies.
• Coordinates with departments to complete procedures during participant visits.
• Retains study records per sponsor requirements.

Education

Secondary degree in social science, health science or related field

LPN or Medical Assistant with CRC experience

Job description

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 2 years experience with the conduction 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.
• 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:

• Secondary degree in social science, health science or related field
• Alternative educational backgrounds may be accepted (i.e., LPN, Medical Assistant, etc) in combination with previous CRC experience
• Must have GCP, IATA, ALCOAC training
• 2 years of experience in the clinical research field
• At least 2 years previous experience as a CRC
• Fully vaccinated against COVID-19 and willing to receive annual flu vaccination

Job Type:

Full-time

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Atlanta, GA 30329: Reliably commute or planning to relocate before starting work (Required)

Work Location:

One location, on site and in person

Rare Disease Research is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, or any other characteristic protected by federal, state or local laws.