Clinical Research Project Manager

The Foundation for Sickle Cell Disease Research (FSCDR) is a human-centric, community-driven organization leading the charge in innovative patient care, clinical treatments, and advocacy. We are not just an organization—we are a movement, relentlessly pursuing a future where no one suffers from the pain of sickle cell disease. We are driven to make this disorder a livable, non-threatening condition. We are seeking passionate individuals to join our team and help expand patient services, advance research, and enhance community advocacy.

JOIN US AND HELP CREATE A PAIN-FREE LEGACY

We are seeking a qualified Clinical Research Project Manager to coordinate and lead efforts in a variety of research activities that are complex and wide in scope. We are looking for someone that loves nonprofit work and is willing to work with our specialized group of patients in the community, as this role requires he role requires comprehensive care. As a Clinical Research Project Manager, you will monitor the progress of clinical studies, at investigative sites, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Key Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinates studies from startup through close-out. Participates in monitoring visits and regulatory audits.
• Determine eligibility of and gather consent from study participants according to protocol. Assists in developing recruitment strategies.
• Coordinate the collection of study specimens and processing. Collects and manages patient and laboratory data for clinical research projects. Manages research project databases, develop flow sheets and other study-related documents, and completes study documents/case report forms.
• Assemble study kits for study visits, monitor scheduling of procedures and charges and coordinating documents. Monitors meetings with sponsors, acting as the primary contact.
• Ensure compliance with research protocols, review and audit case report forms for completion and accuracy with source documents. Prepares regulatory submissions and ensures Institutional Review Board renewal completion.
• Monitor expenditures, adhere to study budgets, and resolve billing issues in collaboration with finance or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.

Qualifications

• Bachelor's Degree in relevant field
• Minimum of three (3) years of clinical research experience
• High level understanding of Phase II and III Clinical Trials
• Excellent communication and interpersonal skills
• Project Management and analysis skills
• Critical thinking and problem-solving skills
• Must have reliable transportation

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or listen. The employee frequently is required to stand; walk; use hands to finger, handle or feel; reach with hands and arms; and may be required to lift up to 25 lbs.

Salary Range

$60,000 - $72,000 annual

Why Work with Us?

• Access to training and career development.

• Collaborate with a dedicated team making a real difference.

Our global impact includes the Journal of Sickle Cell Disease (JSCD), published by Oxford University Press, and our Annual Symposium hosting over 500 experts worldwide to advance new treatments and pursue a cure.

If you’re ready to create change and be part of a movement redefining care for sickle cell disease, apply today!