Site Team Leader

SUMMARY:  

The Site Team Leader (STL)plays a critical role in ensuring clinical trial sites operate efficiently, meet timelines, budget, and quality expectations through remote oversight of clinical sites. Working closely with Regional Site Directors and other Research Operations leaders, this individual will ensure the execution of clinical trial activities in compliance with all applicable regulations. This role will provide close and continued communication with site employees, provide training and mentoring to enhance performance and adherence to best practices. The STL will also ensure engagement of the team.

This role requires close collaboration with cross-functional teams, including site-level leadership, to drive successful clinical trial execution, develop site staff, and position sites for study awards. Responsibilities include site onboarding, maintaining site research readiness, coaching site staff, reviewing site metrics for decision-making, compiling and leading monthly business reviews, and ensuring quality oversight. Key development areas include Adverse Event reporting, Motivational Interviewing, regulatory and compliance updates, and operational changes related to program quality monitoring. By leveraging their expertise in site operations, this individual will craft and execute a strategic approach that enhances site performance, drives business outcomes, and supports the success of Site Operations across their region.

ESSENTIAL DUTIES:

Study Start-Up and Planning:

• Collaborating with study teams and PMs to develop study plans for successful implementation of newly awarded trials. Ensuring adherence to study startup plans in accordance with timelines.
• Completing and/or confirming feasibility questionnaires, as necessary
• Responsible for enrollment strategy to achieve and/or exceed enrollment objectives and working with patient engagement as needed for studies
• Identifying potential risks and developing mitigation strategies. 
• Financial Management and resource allocation for the trial. Responsible for timely activation of clinical trials at sites and ensuring the site is prepared to successfully execute clinical trials. 
• Site-level Vendor management

Site Management and Oversight:

• Manage overall operation of the sites including project plans and resources to ensure compliance with the protocol and contract.
• Participation in preparation and support during all monitoring visits as needed 
• Tracking site enrollment and decision-making for enrollment enhancement
• Managing quality issues and corrective actions
• Ensuring site compliance with GCP guidelines and Good Documentation Practices.
• Coaching, mentoring, and training site staff. to ensure efficient and high-quality site operations
• Maintain an overview of clinical trial operational status or risks and proactively communicate the progress, issues, or protocol revisions that may impact timelines and costs.
• Assists with an understanding of protocols and study procedures.

Team Leadership and Communication:

• Leading site-level staff and managing performance
• Collaborate effectively and interact professionally with team, patients, and study staff (including sponsor/CRO).  
• Developing customer relationships with site CRAs and other sponsor/CRO staff
• Support business development and operations to achieve study awards
• Providing regular updates on trial progress to stakeholders and compiling metrics.
• Responsible for site business reviews at an established cadence

Compliance and Regulatory Oversight:

• Ensuring adherence to all applicable regulatory requirements (ICH-GCP). 
• Preparing for sponsor/CRO and/or regulatory audits. 
• Act as a liaison to the Investigator(s) to ensure appropriate investigator oversight is maintained.
• Perform periodic quality reviews of the investigator site file, protocol deviations, eSource, and other metrics to determine any trends and training needs

SUPERVISORY RESPONSIBILITIES:

• Monitor employee productivity and provide constructive feedback and coaching.
• Manage and supervise the day-to-day operations of assigned team members including managing performance metrics, accountability outcomes and work distribution, performance evaluations
• Assess the work performance of direct reports and identify areas that need improvement
• Set and communicate goals for performance and deadlines in ways that comply with the company’s plans and vision, in addition to departmental objectives.
• Grow and develop the site team including development of succession plans and individual development plans
• Ensure that business goals, deadlines, and performance standards are met according to set benchmarks and established company policy.
• Recommend new employees to the TalentServices team based on an assessment of their performance.
• Ensure adherence to legal and company policies and procedures and partner with TalentServices to undertake disciplinary actions if needed.

QUALIFICATIONS:

• Strong understanding of clinical trial methodologies and regulatory requirements
• Excellent site management skills, including budgeting, timeline, and resourcing management
• Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), relevant Standard Operating Procedures (SOPs) and regulatory requirements
• Excellent coaching and mentorship skills
• Strong interpersonal skills and able to deliver/receive daily constructive feedback
• Ability to work cross functionally and succeed in a team environment.
• Proactive and timely follow-up skills, including the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Excellent written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively. 
• Strong organizational skills ability to accomplish multiple tasks within the agreed-upon timelines, through effective prioritization of duties and functions in a fast-paced environment.
• Proven track record of building and maintaining solid relationships with both internal and external stakeholders in a collaborative manner.
• Self-motivated with the ability to work independently to complete tasks, respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Proven track record of healthcare industry or research experience and building successful relationships. 
• Demonstrated ability to be a prompt decision maker with strong problem-solving skills, while maintaining a high degree of flexibility in adapting to a rapidly changing environment.
• Demonstrated ability to deliver educational presentations, during both small and large group trainings, to customers, peers, and prospects, with measurable results.
• Advanced proficiency with Microsoft 365 applications (Word, Excel, Outlook, PowerPoint, and Teams) and various EDC (Electronic Data Capture) methods.
• Familiarity with CTMS (Clinical Trial Management Systems)

EDUCATION AND EXPERIENCE: 

• Bachelor's degree in life sciences, pharmacy, or a related field or similar experience preferred
• At least Seven (7) years clinical research experience, including experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) 
• Two (2) or more years of experience in line management including change management, managing matrix teams, resourcing management and utilization
• Two (2) or more years of site and study financial management skills
• Quality management and corrective action experience
• CCRC or CCRP certification a plus

ENVIRONMENT:

This is a remote position based on the location of the incumbent’s home and operating in a home-office environment. This role routinely uses standard office equipment such as computers, printers, copiers, and phones.

Occasional evening and weekend work may be required as job duties demand.

Approximately 20-30% of travel may be required to support the position’s responsibilities

PHYSICAL DEMANDS:

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

While performing the duties of this job, the employee is required to:

• Regularly work at a desk using a computer for prolonged periods.
• Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
• Regularly communicate via e-mail, telephone, chat, and webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
• Frequently stand/walk, grasp objects, and perform light/fine manipulation of objects.
• Occasionally move safely over uneven surfaces.
• Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.

While performing the duties of this job, the employee is regularly required to sit, stand, walk, use hands and fingers to feel and handle, reach with arms and hands, talk and hear. While performing the duties of this job, the employee frequently is required to stoop, kneel, crouch, lift weights, or exert a force up to a maximum of 40 pounds.

ADDITIONAL:

Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.

The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job.

The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the positions expectations and responsibilities are met. 

Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.

Bachelor's degree in life sciences, pharmacy, or a related field or similar experience preferred

At least Seven (7) years clinical research experience, including experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) 

Two (2) or more years of experience in line management including change management, managing matrix teams, resourcing management and utilization

Two (2) or more years of site and study financial management skills

Quality management and corrective action experience

CCRC or CCRP certification a plus