What are the responsibilities and job description for the Site Development Associate position at Pinnacle Clinical Research, LLC?
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Summary: The Site Development Associate position will assist with the activation of all De Novo sites at Pinnacle Clinical Research. This individual will assist the Site Development Manager to help maintain the integrity and quality of the research trials according to specific regulations, sponsor guidelines, and institutional policies. In addition to the daily operations of all applicable sites and trials by collaborating closely with the Site Develop Manager, CEO, VP of Clinical Research Operations, VP of Compliance, Director of Clinical Research Operations and other cross-functional representatives, including quality assurance, regulatory services, finance, and data management to ensure successful completion of all site and clinical activities.
Duties and Responsibilities:
Clinical Trial Management:
- Assist with the day-to-day operations of sites and studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Always maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.
- Provide accurate and up-to-date study information and metrics to management; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Assist with training and onboarding new hires on Clinical Research Operations and Compliance SOPs and other applicable trainings
- Assist with various feasibility/study start-up activities to include completion of questionnaires, hosting pre-study meetings, and assigning site resources
- Track key study metrics using tracking tools; create and maintain documents, tables, databases, and spreadsheets)
- Establish strategies for the collection of data, issue identification and resolution, monitoring, and investigator communications
- Provide guidance to research team in developing operational plans to support selected clinical trials
- Compile patient data specified in the study protocols and provided general administrative duties in support of the research studies and team members
- Serve as a liaison with designated service providers to ensure successful deployment of protocol requirements
- Identify training needs and work with site staff to develop and set up trainings in areas of improvement
- Participate in community events and patient recruitment initiatives as needed
- Ensure recruitment activities are optimized and all sites are meeting their study enrollment goals
- Ensure study required training has been completed by staff and PI in a timely manner as to not delay study start-up
- Be available as a resource to provide expertise on protocols and in clinical assessments
- Interacts with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients. Acts as a liaison for clinical trial sponsors, vendors, and sites.
- Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume.
- Attend investigator pre-study visits with sponsor/CRO for upcoming studies
- Creates and completes administrative and study related documents and new study preparation as needed.
- Assists with regulatory submissions as needed
- Coordinates study related activities with involved parties
- Acts as the secondary liaison with vendors
- Assists coordinators with preparation for study monitor visits
- Assist with completion of Fibroscan as needed
- Assist the Marketing Team with open house logistics
- Initiate and establish preliminary relationships with local clinicians and networks.
- Collaborate with internal stakeholders from various departments (Leadership, Operations, Clin Ops, HR, IT, Marketing, etc.).
- Maintain consistent communication with building/property management for site updates
- Assist Marketing endeavors to supply new site staff with appropriate business/office needs (business cards, prescription pads, office supplies, promotional items for events, flyers for site opening, etc.)
- Coordinates and sets up participation in local community events/programs, including Chamber of Commerce, federally qualified health centers, high-yielding clinics, etc. to promote recruitment.
- Coordinates initial lunch & learns, meet & greets with providers in the area.
- Establishes relationships with local media (news, radio, social media) to promote site opening and build patient database.
Clinical Trial Administration:
- Coordinate with staff to track inventory, order supplies, materials, and equipment as needed
- Ensure the proper maintenance of subjects W-9’s to support annual 1099 filings
- Aid in data analysis and identify projects and components needing additional statistical support and consultation
- Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality at each site in the region
- Identify departmental needs, supplies, staffing and equipment goals to continually improve the research process within the established guidelines of the institute
- Work with marketing, HR, IT/facilities to make sure site is equipped for startup (internet setup, referral funnel to site, non-clinical SOPs)
- Work with Summit Clinical Research for site qualifications
- Purchase site equipment and supplies
- Complete applicable HR documentation for new hires
- Assist with employee interviews and scheduling
- Provide timely updates of site progressions
- Appropriately transition site team members to respective managers and departments
- Submit travel documentation including receipts.
- Compile list of local vendors that will be necessary for study start-up (i.e., water supply, security, lab services, pathology services, paper shredding company if applicable, dry ice vendor, office supplies, signage)
Compliance:
- Assist with the planning of independent audits and quality assurance to assess compliance with regulations, guidelines, company policies, and operating procedures for the purpose of preventing and detecting for DeNovo sites
- Assists with corrective action plans, in support of management, to foster completion and achieve compliance.
- Formulates and recommends appropriate process changes to enhance data quality at DeNovo sites
- Perform training and educational programs to ensure clinical research staff are trained in compliance with CFR quality guidelines
- Collaborate with other departments, physicians, and principal investigators to implement the recommended change
- Monitors for protocol compliance to include but not limited to dosing, study procedures, assessment entries, study patient documents to identify protocol noncompliance, and develop action plans to address the deficiencies
- Discusses protocol deviations with appropriate Clinical Trials staff and management
- Collaborates on eSource creation and eSource process implementation at DeNovo sites
- Monitors data management metrics of DeNovo for internal/external queries
- Monitors and facilitates DeNovo sites to meet site/sponsor/CRO data management metrics
- Work in conjunction with the Compliance Department to ensure that all staff are up to date on annual training and documentation is on their record
- Conduct reviews of system set-ups to ensure high quality deliverables in accordance with quality standards and SOP’s
- Assist with the Corrective Action Preventive Action Plan (CAPA) process and implementation as needed
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Qualifications:
- Bachelor’s or advanced degree in life sciences or related field with at least 2 years clinical trial experience. We may consider candidates who have an appropriate combination of education and experience
- Must have strong knowledge of ICH/GCP guidelines
- Must have strong knowledge of protocol and clinical development processes, clinical study design, study planning and management, and monitoring
- Must have excellent interpersonal, written, and verbal communication skills, administrative skills, and computer fluency
- Proficient in all Microsoft Office applications, Clinical Research IO (CRIO), or equivalent CTMS, training provided at onboarding
- Requires proven project management skills and at least 2 years of effective people management or internal promotion based on proven work and leadership experience
- Must complete CITI training before interacting with participants and must re-certify every 3 years
- ACRP (Association of Clinical Research Professionals) or SoCRA (Society of Clinical Research Associates) certification preferred
- Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission
- Comply with the company policies, code of ethics, and guiding values always
- Valid driver's license with maintenance of safe driving record and an automobile that is insured in accordance with the state
- This position will require frequent travel
Competencies:
- Leadership and/or project management experience with the ability to work independently and collaboratively
- Must be an energetic initiative-taker, results, and details oriented, and possess the ability to work effectively in an entrepreneurial environment
- Strong documentation and communication skills, including the ability to provide clear, pragmatic direction and advice to both study team members and external parties such as vendors and consultants
- Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment
- Adept at critical thinking, problem-solving, and executing data-driven solutions with the ability to work well under pressure
- Excellent working knowledge of medical and research terminology
- Superior organizational skills that include the ability to prioritize, delegate, direct, support, and evaluate others’ work and follow through on tasks and projects
- Must possess strong team building skills to lead a highly productive team to accomplish short and long-term goals, both individually and organizationally
- Encourage a positive collaborative environment at each site in the region
- Lead by example and display a prominent level of integrity and professionalism
- Ability to provide and receive feedback in a constructive and helpful manner to elevate the success of colleagues and the organization
Work Environment and Physical demands:
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Work is performed in an office/laboratory and/or a clinical environment.
- Exposure to biological fluids and/or bloodborne pathogens.
- Personal protective equipment required such as protective eyewear, garments, and gloves.
- Heavy travel between all Pinnacle and De Novo locations required
- Occasional domestic/international travel may be required
- Ability to work in an upright and/or stationary position for 6-10 hours per day.
- Frequent mobility required.
- Occasional squatting, kneeling, or bending.
- Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
Perks of working at Pinnacle Clinical Research:
- 401k
- Medical, dental, vision, long term disability, short term disability, HSA, and life insurance
- 3 weeks of paid time off
- 14 paid company holidays
- Tranquility Room (specific locations only)
- Pinnacle Gym (specific locations only)
- Scrub voucher (specific positions apply)
- And more!
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
