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Job Summary:

The Clinical Team Lead is responsible for providing day-to-day leadership, oversight, mentoring, and performance support to Clinical Research Associates (CRAs) and related clinical research delivery staff within Spaulding Clinical. This role supports the compliant execution, documentation, monitoring, and delivery of Phase I and II clinical pharmacology studies and related clinical research projects, with a focus on quality, participant safety, data integrity, inspection readiness, sponsor satisfaction, and operational consistency.

The Clinical Team Lead serves as the primary operational and quality resource for assigned CRA staff and may provide direct supervision, workload coordination, training, coaching, and performance feedback. CRAs will report to the Clinical Team Lead unless otherwise designated by management. The role partners closely with Project Management, Quality Assurance, Regulatory, Data Management, Biometrics, and other departments to ensure that studies are conducted in accordance with the protocol, informed consent, Good Clinical Practice (GCP), applicable regulations, sponsor requirements, internal SOPs, and Spaulding Clinical standards.

The Clinical Team Lead may also support assigned study oversight activities, serve as a senior CRA or lead CRA on complex studies, assist with sponsor communication and escalations, and contribute to the development and refinement of CRA processes, tools, training materials, and quality practices.

Essential Duties and Responsibilities:

CRA Leadership and Staff Oversight

• Provide day-to-day leadership, coaching, mentoring, and guidance to CRAs and related clinical research staff.
• Serve as the direct supervisor or designated reporting leader for assigned CRAs, including support for workload management, prioritization, performance feedback, and professional development.
  • Conduct regular one-on-one meetings with CRA staff to review workload, study assignments, deliverables, performance expectations, training needs, quality concerns, and development goals.
  • Support hiring, onboarding, training, competency development, and ongoing performance management for CRA team members as assigned.
  • Establish and reinforce expectations for CRA performance, communication, documentation quality, issue escalation, sponsor interaction, and inspection readiness.
  • Promote a culture of accountability, urgency, collaboration, professionalism, continuous improvement, and quality-first study execution.
  • Escalate performance concerns, resource constraints, compliance risks, staff development needs, and operational barriers to management in a timely and professional manner.

Clinical Oversight and Study Delivery Support

• Oversee CRA support for Phase I-II clinical pharmacology studies, including study startup, initiation, conduct, monitoring, closeout, and sponsor-facing deliverables as assigned.
• Maintain strong working knowledge of Spaulding Clinical processes, SOPs, Phase I-unit operations, study conduct expectations, documentation standards, and sponsor delivery requirements.
• Partner with Project Management and operational leaders to support project timelines, study readiness, risk management, issue resolution, action item follow-up, and successful study delivery.
• Ensure assigned CRA activities are aligned with protocol requirements, informed consent, GCP, applicable regulations, sponsor expectations, and Spaulding Clinical SOPs.
• Provide senior-level review or oversight of CRA monitoring activities, source/document review, essential document review, monitoring reports, action item trackers, and follow-up communications.
• Identify, document, communicate, and escalate protocol deviations, documentation deficiencies, quality concerns, participant safety concerns, and operational risks promptly and appropriately.
• May serve as Lead CRA, Senior CRA, or primary clinical operations quality contact for assigned studies, complex projects, sponsor engagements, or coverage needs.

CRA Processes, Training, and Quality Standards

• Develop, implement, and refine CRA tools, templates, workflows, checklists, clinical monitoring plans and expectations, documentation practices, and training materials to improve consistency, efficiency, and quality.
• Ensure CRA staff are trained on applicable SOPs, GCP expectations, protocol requirements, monitoring practices, documentation standards, escalation pathways, and sponsor-specific requirements.
• Support competency assessment and ongoing training of CRA staff through direct observation, documentation review, coaching, and review of CRA deliverables.
• Standardize CRA practices across assigned studies while allowing appropriate flexibility based on protocol complexity, sponsor needs, and project risk.
  • Monitor CRA deliverable quality, timeliness, action item closure, documentation completeness, and adherence to internal processes and sponsor commitments.
  • Lead or support continuous improvement initiatives related to monitoring, documentation quality, data integrity, study file completeness, CRA workflows, and inspection readiness.
  • Communicate process updates, department expectations, project priorities, and assigned action items to CRA staff clearly and in a timely manner.

Cross-Functional Collaboration and Sponsor Support

• Collaborate with Project Management, Quality Assurance, Regulatory, Data Management, Biometrics, Contracts, Finance, and other departments to support coordinated study execution.
• Serve as an escalation point for CRA-related study issues, documentation concerns, quality risks, operational barriers, sponsor questions, and action item resolution needs.
• Participate in project meetings, sponsor calls, governance discussions, study kickoffs, readiness meetings, closeout meetings, lessons-learned discussions, audits, and inspections as assigned.
• Communicate professionally with sponsors, vendors, auditors, investigators, study staff, and internal stakeholders regarding CRA activities, study status, documentation expectations, risks, and follow-up needs.
• Partner with Project Management to ensure client expectations related to CRA activities, documentation, issue follow-up, and study oversight are clearly understood and managed.
• Support bid defense preparation, proposal input, sponsor qualification visits, and client relationship activities when CRA or clinical oversight expertise is needed.

Compliance, Quality, and Inspection Readiness

• Maintain current knowledge of Good Clinical Practice, ICH guidelines, FDA regulations, applicable laws, ethical standards, internal SOPs, and clinical trial documentation expectations.
• Promote accurate, attributable, legible, contemporaneous, original, and complete study documentation across CRA-supported activities.
• Partner with Quality Assurance to support audit readiness, inspection readiness, CAPA activities, root cause analysis, quality event follow-up, and process improvement efforts as needed.
• Ensure CRA staff recognize and escalate clinical practice concerns, informed consent concerns, protocol deviations, participant safety issues, data integrity concerns, and potential compliance risks.
• Support timely resolution of monitoring findings, audit observations, data discrepancies, action items, quality issues, and study team follow-up items.
• Review or support review of Trial Master File, study file, source documentation, essential documents, and applicable study records for completeness, accuracy, and readiness for sponsor review, audit, or inspection.
• Demonstrate professionalism, sound judgment, discretion, accountability, and leadership in all interactions with staff, sponsors, participants, vendors, auditors, and external partners.
• Other functions as directed and delegated

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications                            

• Ability to read, write, and interpret the English language.

• Strong working knowledge of clinical research operations, Phase I clinical pharmacology study conduct, GCP, FDA regulations, ICH guidelines, informed consent requirements, and clinical trial documentation standards.
• Demonstrated knowledge of CRA monitoring practices, source documentation review, essential document review, protocol deviation identification, issue escalation, action item follow-up, and study file quality expectations.
• Demonstrated leadership skills with ability to coach, mentor, train, direct, delegate, and hold staff accountable to expectations.
• Ability to manage workload, priorities, deliverables, and competing deadlines for self and assigned CRA staff in a fast-paced regulated environment.
• Excellent attention to detail and ability to produce and review accurate, complete, and timely documentation.
• Strong analytical, problem-solving, organizational, time management, and decision-making skills.
• Professional written and verbal communication skills, including ability to interact effectively with sponsors, auditors, vendors, investigators, study staff, and cross-functional colleagues.
• Ability to identify risks, escalate concerns appropriately, drive action items to resolution, and communicate issues clearly and professionally.
• Demonstrated professionalism, sound judgment, accountability, discretion, and commitment to quality and participant safety.
• Ability to support change management, process improvement, staff development, and operational standardization.
• Proficient computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, clinical trial systems, electronic data capture systems, eTMF/CTMS tools, and other applicable technologies.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far. 
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

Required

• Bachelor's degree in life sciences, healthcare, nursing, clinical research, business, project management, or a related field; equivalent combination of education and relevant clinical research leadership experience may be considered.
• Progressive clinical research experience with at least five (5) years demonstrated CRA/monitoring, or Clinical Trial Manager experience.
• Prior experience mentoring, leading, supervising, training, or coordinating CRA staff or clinical research staff.
• Experience supporting Phase I-II, clinical pharmacology, CRO, pharmaceutical, biotech, academic research, or clinical research unit studies.
• Strong knowledge of clinical trial conduct, GCP, FDA regulations, ICH guidelines, source documentation, protocol compliance, essential document requirements, and inspection readiness expectations.
• Demonstrated experience identifying and escalating protocol deviations, documentation deficiencies, quality risks, data integrity concerns, and participant safety concerns.
• Ability to manage multiple priorities, lead staff through competing deadlines, and communicate effectively with sponsors and cross-functional teams.

Preferred

CCRA, CCRP, ACRP-CP, SOCRA, PMP, or other relevant clinical research, or quality certifications

Prior Lead CRA, Senior CRA, Clinical Team Lead, Clinical Operations Lead, or CRA management experience in a Phase I clinical pharmacology unit or CRO environment.

Experience with cardiac safety, thorough QT, first-in-human, SAD/MAD, bioequivalence, drug-drug interaction, food effect, renal/hepatic impairment, or other clinical pharmacology study designs.

Experience supporting sponsor audits, regulatory inspections, CAPAs, root cause analysis process improvement initiatives, and CRA training programs.

Experience with EDC, CTMS, eTMF, electronic source, clinical trial management tools, sponsor portals, and CRA workflow tracking tools.