Key Responsibilities and Required Skills for Clinical Research Coordinator Lead

🎯 Role Definition

The Clinical Research Coordinator Lead (CRC Lead) is a hands-on, operational leader who manages day-to-day coordination of clinical trials while providing supervisory oversight, staff development, and process improvement across studies. This role is the primary point of contact between investigators, sponsors, clinical teams, and regulatory bodies to ensure protocol adherence, participant safety, data integrity, and timely study delivery. The CRC Lead balances patient-facing activities (consenting, visits, safety assessments) with administrative responsibilities (regulatory maintenance, monitoring readiness, budget and billing reconciliation) and leads continuous quality improvement initiatives.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) / Senior CRC
Research Assistant or Clinical Trial Assistant (CTA)
Registered Nurse (RN) or Clinical Study Specialist with research experience

Advancement To:

Clinical Research Manager / Research Operations Manager
Clinical Project Manager / Clinical Trial Manager
Director of Clinical Research / Head of Clinical Operations

Lateral Moves:

Regulatory Affairs Specialist / IRB Coordinator
Clinical Quality Assurance / Clinical Compliance Auditor
Clinical Research Educator / Training Lead

Core Responsibilities

Primary Functions

Oversee and coordinate all operational aspects of clinical trials assigned to the portfolio, ensuring each study is executed in strict compliance with protocol procedures, informed consent, institutional policies, ICH-GCP guidelines, and applicable regulatory (FDA/EMA) requirements.
Supervise, mentor, and evaluate a team of clinical research coordinators and study staff, including hiring, onboarding, performance reviews, training plans, and development of competency matrices to ensure high-quality execution and career progression.
Lead participant recruitment and retention strategies by designing targeted outreach plans, tracking enrollment metrics, troubleshooting barriers to accrual, and partnering with referring clinicians and community stakeholders to meet or exceed enrollment targets.
Direct the informed consent process for complex studies, ensuring consent documents are current, participants are fully informed, and consent is properly documented and stored in accordance with IRB-approved procedures and HIPAA privacy rules.
Manage visit scheduling, protocol-driven procedures, and subject flow to ensure data completeness and participant safety while minimizing burden; proactively resolve scheduling conflicts and protocol deviations.
Maintain and oversee regulatory documentation (Regulatory Binder / eTMF), including IRB submissions and renewals, protocol amendments, delegation logs, CVs, medical licensure, and training records to guarantee monitoring- and audit-readiness.
Serve as the primary liaison with sponsors, clinical research organizations (CROs), study monitors, and auditors during on-site and remote monitoring visits; prepare documentation, respond to findings, and implement corrective action plans.
Ensure source documentation is complete, accurate, and contemporaneous; review case report forms (CRFs) and electronic data capture (EDC) entries for accuracy and resolve data queries in collaboration with data management.
Oversee investigational product (IP) accountability and handling, including receipt, storage, dispensing, reconciliation, temperature monitoring, and return/destruction per protocol and sponsor/CRO requirements.
Lead safety surveillance activities by triaging, documenting, and reporting adverse events (AEs), serious adverse events (SAEs), and unanticipated problems to the Principal Investigator (PI), sponsor, and IRB per timelines and regulatory requirements.
Coordinate specimen handling and processing workflows (blood, tissue, imaging), manage shipping chains, ensure chain-of-custody documentation, and liaise with central labs/vendors to maintain sample integrity and timely analysis.
Conduct risk-based source data verification and internal quality checks; identify trends and systemic issues and drive continuous improvement initiatives to increase data quality and operational efficiency.
Oversee study budgets, feasibility assessments, and billing compliance; collaborate with contracts and finance teams to track study costs, process invoices, and ensure compliance with sponsor and institutional billing policies.
Develop, implement, and maintain site standard operating procedures (SOPs), study-specific processes, and checklists to promote consistency across the team and improve operational throughput and compliance.
Lead pre-study feasibility and startup activities: site selection input, study kickoff, site initiation visit preparation, training of site staff, and coordination of equipment and supply procurement required for study activation.
Build and maintain strong relationships with cross-functional teams including investigators, nursing leadership, pharmacy, laboratory services, imaging, and outpatient clinics to ensure integrated, patient-centered trial conduct.
Generate, maintain, and present study metrics and KPI dashboards (enrollment, retention, query resolution, monitoring findings, regulatory status) to leadership and stakeholders to support data-driven decision-making.
Oversee vendor relationships and subcontractor activities (central labs, imaging core labs, courier services), ensuring contractual deliverables, quality standards, and timely communication are met.
Manage and adjudicate protocol deviations and non-compliances: investigate root causes, prepare corrective and preventive action (CAPA) plans, and lead implementation and follow-up to close gaps.
Support development and review of study documents including case report forms, study manuals, source documentation templates, and patient-facing materials to ensure clarity and regulatory compliance.
Act as escalation point for complex participant issues, clinical emergencies, or protocol interpretation questions, coordinating with the PI and clinical leadership to determine risk mitigation and participant safety actions.
Facilitate training sessions and competency assessments for new protocols, regulatory updates, and GCP refresher courses; maintain training records and ensure ongoing education requirements are met.
Coordinate multi-site communication when acting as lead site liaison, organizing investigator meetings, distributing study updates, and harmonizing processes across participating sites to ensure consistency and compliance.

Secondary Functions

Support protocol development and feasibility assessment by providing operational insights, recruitment estimates, and input on visit schedules, procedures, and participant burden.
Assist with grant applications, IRB-ready documentation, and study startup deliverables to accelerate site activation timelines.
Contribute to manuscript preparation, abstracts, and poster development by organizing and summarizing study data and operational lessons learned.
Participate in institutional committees related to clinical research governance, patient safety, enrollment strategy, and cross-departmental process improvement.
Lead or support quality initiatives such as mock audits, process mapping, root cause analysis, and implementation of best practices to improve audit/inspection readiness.
Manage inventory and purchasing for study-specific supplies and equipment; establish systems to prevent stockouts and control costs.
Serve as backup for other clinical research functions (e.g., regulatory coordinator, data manager, research nurse) during staff absences to maintain continuity of operations.
Participate in community outreach, patient education events, and recruitment fairs to raise awareness of clinical trial opportunities and improve diversity in enrollment.
Work with IT and informatics teams to optimize EDC workflows, eConsent platforms, ePRO systems, and integration with electronic health record (EHR) systems for streamlined data capture.
Support ad-hoc reporting requests for leadership, sponsors, and institutional stakeholders related to enrollment, milestones, and compliance.

Required Skills & Competencies

Hard Skills (Technical)

Proven proficiency with electronic data capture (EDC) systems such as REDCap, Medidata Rave, Oracle Clinical, or similar, including query management and data reconciliation.
Experience with Clinical Trial Management Systems (CTMS) e.g., OnCore, Veeva; ability to maintain study calendars, visit logs, and subject records.
Strong working knowledge of regulatory requirements including ICH-GCP, FDA regulations, EMA guidance, and IRB processes for human subjects research.
Demonstrated experience preparing and maintaining regulatory binders/eTMF, performing regulatory submissions, and responding to IRB/sponsor queries.
Competence in adverse event (AE/SAE) reporting workflows, safety reporting timelines, and safety database documentation.
Familiarity with investigational product (IP)/drug-device accountability processes, pharmacy coordination, and cold chain management.
Experience with protocol deviation tracking, CAPA development, and implementation of corrective actions.
Proficient in Microsoft Office suite (Word, Excel, PowerPoint) with advanced Excel skills for reporting, pivot tables, and KPI dashboards.
Working knowledge of HIPAA, patient privacy protections, and informed consent best practices.
Experience coordinating specimen logistics and working with central labs, imaging cores, and specialized vendors.
Budget tracking, billing reconciliation, and basic financial literacy related to study invoicing and contract deliverables.
Experience leading monitoring visits and audit preparation, including hosting sponsor/CRO monitors and external auditors.

Soft Skills

Demonstrated leadership and team development skills with the ability to coach, mentor, and motivate staff while holding teams accountable for quality and timelines.
Exceptional verbal and written communication skills for interactions with investigators, sponsors, IRBs, vendors, and study participants.
Strong organizational ability and attention to detail to manage competing priorities across multiple studies.
Critical thinking and problem-solving aptitude to identify operational bottlenecks and implement pragmatic solutions.
High emotional intelligence and patient-centered approach for sensitive interactions with participants and families.
Adaptability and resilience in a fast-paced clinical research environment with shifting priorities and timelines.
Stakeholder management skills, including the ability to influence cross-functional teams and escalate appropriately.
Time management and prioritization skills to balance administrative tasks with participant-facing responsibilities.
Ethical judgment and integrity in handling confidential information and reporting research findings.
Continuous improvement mindset with the ability to implement process changes and measure impact.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Nursing (BSN), Biological Sciences, Public Health, Health Sciences, or a related field. OR equivalent clinical research experience combined with relevant certifications.

Preferred Education:

Bachelor’s degree with RN licensure preferred for complex interventional trials; Master’s degree in Clinical Research, Public Health, or related field is advantageous.
Professional certification preferred: Certified Clinical Research Coordinator (CCRC), ACRP-CP, SoCRA certification, or CCRA.

Relevant Fields of Study:

Nursing (BSN/RN)
Biology / Biomedical Sciences
Public Health / Epidemiology
Pharmacology / Pharmacy Sciences
Clinical Research / Health Sciences

Experience Requirements

Typical Experience Range:

4–8 years of progressive clinical research experience with demonstrated operational leadership; minimum 2 years in a supervisory or lead CRC role preferred.

Preferred:

5+ years coordinating industry-sponsored and/or investigator-initiated clinical trials, including experience with complex protocols (oncology, cardiovascular, CNS, device studies), direct sponsor/CRO interaction, and successful hosting of monitoring visits and audits.
Proven track record of meeting enrollment targets, managing cross-functional teams, and improving operational processes.
Familiarity with electronic health record (EHR) integration, eConsent/ePRO platforms, and remote/virtual visit workflows a plus.
Training and certifications in GCP, human subjects protection, and relevant therapeutic area experience are highly desirable.