Lead Clinical Research Coordinator

ProPharma • Raleigh, NC

1d • Remote

About The Position

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Clinical Research Coordinator (CRC) is a specialized research professional responsible for managing, facilitating, and coordinating daily clinical trial activities. The CRC plays a critical role in ensuring protocol compliance, data integrity, and participant safety from study initiation through completion. CANDIDATE MUST RESIDE IN NYC FOR THIS OPPORTUNITY.

Requirements

• Minimum 4–5 years of experience managing multiple Phase II-III industry-sponsored clinical trials as the lead coordinator
• Bachelor's degree required; clinical credential (RN, LPN, MA) or Master's degree a plus
• GCP Certification required; CCRC or CCRP certification strongly preferred
• Demonstrated mastery of ICH/GCP guidelines, FDA regulations, and CFR requirements governing human subject research
• Experience with EDC systems, eSource documentation (Preferably CRIO)
• Proficiency in medical terminology, clinical documentation, and good documentation practices
• Demonstrated problem-solving and strategic decision-making ability; ability to react calmly and effectively in emergent situations
• Strong organizational skills with the ability to independently manage multiple concurrent protocols
• Clear, professional verbal and written communication skills
• Proficient in Microsoft Office Suite, Google Workspace and clinical research platforms
• Phlebotomy experience a plus
• Bilingual - English & Spanish Required
• Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace.
• Study Tearn experience is ideal.
• Critical thinking skills.
• Strong communication Skills (verbal and written).
• Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed.
• Working location that has the ability to maintain privacy.
• Current knowledge of and the ability to apply ICH / GCP and applicable regulations and guidelines.
• Competent in the application of standard business procedures including but not limited to SOPs, global regulations.
• Well organized and able to multitask.
• Able to work independently and as a team member.
• Able to take initiative while following directives.
• Bachelor's degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.

Nice To Haves

• clinical credential (RN, LPN, MA) or Master's degree a plus
• CCRC or CCRP certification strongly preferred
• Phlebotomy experience a plus
• Study Tearn experience is ideal.

Responsibilities

• Independently conduct and manage assigned clinical trials in accordance with study protocols, GCP/ICH guidelines, FDA regulations, and company SOPs, from site initiation through study close-out
• Implement and coordinate all aspects of assigned trials including start-up activities, vendor management, subject recruitment and retention, source document development, visit scheduling, regulatory document collection, protocol training, EDC data entry, query resolution, amendment implementation, and close-out reporting
• Assist with study operations and workflow optimization to support successful protocol execution.
• Manage, monitor, and report adverse events, serious adverse events (SAEs), and protocol deviations to Sponsors and IRBs with accurate and timely documentation
• Prepare for and lead monitoring visits, audits, and inspections; resolve data queries and protocol issues identified by monitors in a timely and professional manner
• Perform procedures and assessments per protocol, including phlebotomy, ECGs, drug preparation and administration, and lab specimen processing
• Evaluate and screen potential subjects for protocol eligibility; manage informed consent and participant retention activities
• Collaborate with investigators, sponsors, CROs, labs, and internal teams to ensure protocol requirements are fully understood and consistently executed
• Maintain working knowledge of study protocols, lab manuals, equipment calibration, and study supply inventory
• Serve as point of contact for day-to-day Site communications, document submissions and activity coordination.
• Support pre-screening, screening and recruitment activities, as assigned.
• Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator.
• Perform data-entry, evaluate and respond to system queries and monitor clinical databases as assigned.
• Establish and maintain timely Site communication as assigned.
• Maintain documentation which complies with IRB/FDA policies.
• Assist with study closeout.
• Assist site with other study-related activities as directed.
• Other duties as assigned.

Benefits

• We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level