Site Manager

Atlas Family•Centreville, AL

7d•Onsite

About The Position

Job Description: Supervise Clinical staff and the administration of clinical trials. Ability to supervise and train employees, including organizing, prioritizing, and scheduling work assignments. Site Manager oversees all members of the practice participating in clinical research Strong understanding of financials and performance metrics Excellent people skills and proven success leading and managing teams Professional and highly motivated “self-starter” with the ability to exercise initiative Must have the ability to work as a team leader as well as independently while managing a variety of study related projects simultaneously Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances) Strong written, verbal communication and interpersonal skills Demonstrated ability to exercise standard universal precautions; in the alternative, the ability to quickly learn and apply Universal Precautions Demonstrated ability to operate basic office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers Ability to be ambulatory most of the workday Demonstrated ability to work with IRB submissions and correspondence Comply with OSHA regulations Job Summary: Supervise the implementation of research studies. Adhere to study protocols, educate research staff and policies, processes, and procedures. Determine effective strategies for promoting/recruiting research participants and retaining participants. The items listed below are the responsibilities and duties that are expected to be completed by the area manager on a routine basis to ensure that the sites of supervision-n are operating effectively and efficiently. The Area Manager will operate under 45CFR 46 (the common rule) to maintain protections for participants in research. Ability to administer prescribed treatments according to protocol Demonstrated excellence in performance of standard operating procedures Critical thinking, analytical, mathematical skills Regular and predictable attendance is an essential function This position will be responsible for performing diverse managerial and administrative responsibilities requiring analysis, sound judgement, a high level of knowledge of study protocols and strong business management skills To consistently embody KUR’s Core Values. Excellence and Consistency Respect for our Subjects, Sponsors and Team Members Manage all clinical research staff including investigators, coordinators, lab(s) & to ensure optimal performance on each study Potential of managing the operations of one or more sites Ensure all personnel obtain detailed knowledge of all components of study protocol through review of study and training, prior to the study effective date, to ensure protocol compliance Review with the research team all components of the study prior to initiation date to ensure complete understanding and acceptance of roles and responsibilities during study Provide direction and support to research team during subject screening to ensure qualified subjects are identified and enrolled in the study in a timely manner Ensure the research team develops and implements an effective enrollment plan to ensure subject enrollment consistent with the sponsor’s protocol and enrollment period In cooperation with the Principal Investigator, oversee all studies and ensure they are conducted according to FDA regulations, GCP guidelines and KUR’s SOP’s Participate in the process of managing sites/revenues for maximum site performance Ensure accurate and complete drug/device distribution and accountability records of all investigational products that are maintained, and the product is stored according to requirements Ensure prompt reporting of all adverse events to the principal investigator, sponsor, and IRB in compliance with FDA regulations and sponsor requirements Ensure serious adverse events are reported by the Coordinators to the Principal Investigator immediately, the sponsor within 24 hours and the CRO and IRB promptly Ensure case report forms are complete and accurate and maintained by Coordinators/Data Managers per FDA requirements, sponsor requirements and KUR’s SOP’s Ensure Vendor Assessments are completed for any vendor used that can affect the integrity of our data Ensure all laboratory tests are performed at the designated lab facility completely, accurately, and according to established procedures and study protocol Meet and greet monitors during their visits Implement all KUR SOPs, site manual procedures, and ensure regular compliance Implement and monitor Key Performance Indicator (KPI) Metrics Development and Reporting Ensure the research team provides sponsors with required information that is complete and accurate per research agreement Inform sponsor, QA, Regulatory and VP of Compliance of prospective FDA audits and determine steps necessary to correct deficiencies identified in an FDA audit and implement changes Full responsibility for developing the site team, including recruiting, interviewing, hiring, coaching, documenting, and administering progressive discipline process Empower team members to take responsibility for their jobs and goals Delegate responsibility and expect accountability and regular feedback Hire, train, and develop new team members to meet organizational needs Consciously create a workplace culture consistent with the overall organization's and that emphasizes the identified mission, vision, guiding principles, and values of the organization Provide timely feedback on employee performance, helping to develop a team members skill where needed, and addressing performance problems Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities Coordinate and lead at staff meetings at least once per month Lead and administer employee performance evaluations and provide feedback on areas of improvement Create, lead, and motivate teams that achieve maximum site level performance Travel to Investigator Meetings as needed Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed Be able to step up and fill in as coordinator and assist in lab, if applicable Other duties as assigned Assist with ensuring that the Investigator Site File (ISF) is maintained. Spot check eDocs to ensure all study logs/documents are being maintained including running logs that must be uploaded weekly. Spot check minimum of twenty (20) eSource visit documentations per week. Ensure all sponsor and data team queries are resolved within 48 hours. Ensure all follow up/action items listed on follow-up letters are resolved in 48 hours. Check IRB portals daily to ensure that site teams are using the correct and most recent version of the informed consent/assent forms. Relay this to CRC’s every morning. Ensure all sample shipments are completed per protocol & sponsor deadlines are met. Ensure all equipment that is rented has not expired and file receipt of payment. Manage and update inventory tracking spreadsheet. Identify common errors that site staff are making and ensure that a resolution is implemented to prevent and/or address these errors. Keep a record of these errors and re-train, as necessary. Ensure all sponsor sent packages are received, opened, and confirmed immediately and placed in the appropriate location, i.e., site storage, -20 Freezer, refrigerator, etc. Ensure all PI/Sub-Investigator signatures, wet and electronic, are collected in a timely manner. Participate in mock audits/training in conjunction with Regulatory, QA and SIV teams. Initiate email process to ensure that research team are well trained on the protocol prior to green light. After we receive greenlight from sponsor/CRO and all mocks and documents completed, initiate greenlight to research team. After site selection, send sponsor/CRO introduction of executive team (point of contact for budgets & contracts, project management, regulatory & quality assurance team). Communicate with sponsors on study related requests including closeouts, data queries, study updates, inventory management and documentation requests. Run assigned studies; recruit subjects, manage inventory, develop recruitment strategies (i.e., visual displays, outreach etc.) monitor storage/freezers, manage shipments coming in and being sent out. Manage relationships with clinics; ensure protocol understanding, provide training with any gaps in knowledge, provide reports and updates on study progress; ensure compliance documentation. Ensure CTMS is up to date, that data is entered correctly, upload documentation (audit if these are signed correctly), manage sponsor requests. Distribute kick off call invites and attend all kickoff calls. Ensure all temperature alarms are addressed within 24 hours and maintain site temperature logs/calibrations. Notify monitoring system when new probes/nodes are needed within 45 days of expiration. Assist with SIV site visits from sponsor in conjunction with CRC, QA, PM, PI. Conduct SIV Prep Calls with internal staff to mock protocol and comprise a list of questions/ clarifications needed by the sponsor/CRO. Create and update MSOP, SOP and work instructions. Complete EDC trainings that sponsors require. Operate ethically at all times, adhering to SOP’s, and Good Clinical Practice. Work in conjunction with Regulatory department on IBC submissions and ensure that areas are properly equipped with PPE, biosafety cabinets, hoods, or benches and that they are in proper working condition and calibrated as needed. Administrative responsibilities/duties: Distribute kick off call invites and attend all kickoff calls. Schedule monitoring visits and close out visits. Ensure to loop in A/R team once COV has been scheduled for invoicing. Ensure documents are ready for any IMV & COV (relay information to the site research team & regulatory team). Work in conjunction with all areas of KUR staff (Regulatory, QA, Operations, Finance, BD, etc.). Ensure all locations have appropriate staff coverage to avoid enrollment interruptions. Ensure GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC trainings are completed within 2 weeks of hire and renewed in a timely fashion. Collaborate with project manager to gather information for completion of feasibility questionnaires in a timely manner. Stay informed on clinic trends and provide those trends to BD Team. Keep clinic staff, providers, medical assistants/nurses informed on new studies and patient populations needed for study recruitment. Provide monthly updates regarding study progress to the PI/Sub-investigators. Update current study list spreadsheet weekly & ensure all action items are completed. Maintain 3rd party relationships per sponsor requirements (dry ice vendors, courier services, etc.). Maintain site supplies, including but not limited to, general site supplies, sponsor specific, and Realtime pay cards. Ensure Realtime funds remain above the threshold. Notify monitoring systems internal point of contact when new probes/nodes are needed within 45 days of expiration. Order supplies & placing rental (centrifuge, temp tales, ultrasound) Maintain record of Covid-19/Influenza A/B testing & positivity numbers in all clinics you oversee. Ensure destruction/return of study supplies/equipment/investigational product prior to/on close out visits as directed by the sponsor. Work with Regulatory dept to ensure record retention is adhered to for all studies.

Requirements

Strong understanding of financials and performance metrics
Excellent people skills and proven success leading and managing teams
Professional and highly motivated “self-starter” with the ability to exercise initiative
Ability to work as a team leader as well as independently while managing a variety of study related projects simultaneously
Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine
Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances)
Strong written, verbal communication and interpersonal skills
Demonstrated ability to exercise standard universal precautions; in the alternative, the ability to quickly learn and apply Universal Precautions
Demonstrated ability to operate basic office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers
Ability to be ambulatory most of the workday
Demonstrated ability to work with IRB submissions and correspondence
Comply with OSHA regulations
Ability to administer prescribed treatments according to protocol
Demonstrated excellence in performance of standard operating procedures
Critical thinking, analytical, mathematical skills
Regular and predictable attendance is an essential function
This position will be responsible for performing diverse managerial and administrative responsibilities requiring analysis, sound judgement, a high level of knowledge of study protocols and strong business management skills
To consistently embody KUR’s Core Values. Excellence and Consistency Respect for our Subjects, Sponsors and Team Members
Minimum of 5 years of experience in clinical research with 7-10 years preferred.
Strong site management experience is highly desirable.
Proven ability to lead and manage teams effectively.
Excellent communication, interpersonal, and organizational skills.
Demonstrated ability to multi-task and adapt to dynamic therapeutic areas.
CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within the first two weeks of hire (training provided).
Bachelor’s degree in a related field required, master’s degree preferred.
Ability to travel locally and nationally as needed.
Must be based out of the site office.
Willingness to work flexible hours and take on tasks outside of the current role as needed.
Ability to step in as a coordinator or assist in the lab if applicable.

Nice To Haves

Excellent multi-tasking skills, attention to detail and the ability to work independently.
Ability to work closely with personnel from various departments and all levels of management.
Effective verbal and written communication skills as well as conflict resolution abilities.
Demonstrate good judgment and problem-solving skills.
Organize tasks, set priorities, meet deadlines, and manage multiple tasks.
Experience in managing multiple stakeholders in challenging new areas.
Research and Management Experience.
Experience working in Real-Time Clinical Trial Management (CTMS) preferred.
Experience with Electronic Data Capture systems and Real-Time Clinical Trial Management (CTMS) preferred.
Experience working in Microsoft Teams, Microsoft Office, PDF Filler, CTMS and DocuSign.

Responsibilities

Supervise Clinical staff and the administration of clinical trials.
Supervise and train employees, including organizing, prioritizing, and scheduling work assignments.
Oversee all members of the practice participating in clinical research
Operate under 45CFR 46 (the common rule) to maintain protections for participants in research.
Administer prescribed treatments according to protocol
Manage all clinical research staff including investigators, coordinators, lab(s) & to ensure optimal performance on each study
Manage the operations of one or more sites
Ensure all personnel obtain detailed knowledge of all components of study protocol through review of study and training, prior to the study effective date, to ensure protocol compliance
Review with the research team all components of the study prior to initiation date to ensure complete understanding and acceptance of roles and responsibilities during study
Provide direction and support to research team during subject screening to ensure qualified subjects are identified and enrolled in the study in a timely manner
Ensure the research team develops and implements an effective enrollment plan to ensure subject enrollment consistent with the sponsor’s protocol and enrollment period
Oversee all studies and ensure they are conducted according to FDA regulations, GCP guidelines and KUR’s SOP’s
Participate in the process of managing sites/revenues for maximum site performance
Ensure accurate and complete drug/device distribution and accountability records of all investigational products that are maintained, and the product is stored according to requirements
Ensure prompt reporting of all adverse events to the principal investigator, sponsor, and IRB in compliance with FDA regulations and sponsor requirements
Ensure serious adverse events are reported by the Coordinators to the Principal Investigator immediately, the sponsor within 24 hours and the CRO and IRB promptly
Ensure case report forms are complete and accurate and maintained by Coordinators/Data Managers per FDA requirements, sponsor requirements and KUR’s SOP’s
Ensure Vendor Assessments are completed for any vendor used that can affect the integrity of our data
Ensure all laboratory tests are performed at the designated lab facility completely, accurately, and according to established procedures and study protocol
Meet and greet monitors during their visits
Implement all KUR SOPs, site manual procedures, and ensure regular compliance
Implement and monitor Key Performance Indicator (KPI) Metrics Development and Reporting
Ensure the research team provides sponsors with required information that is complete and accurate per research agreement
Inform sponsor, QA, Regulatory and VP of Compliance of prospective FDA audits and determine steps necessary to correct deficiencies identified in an FDA audit and implement changes
Develop the site team, including recruiting, interviewing, hiring, coaching, documenting, and administering progressive discipline process
Empower team members to take responsibility for their jobs and goals
Delegate responsibility and expect accountability and regular feedback
Hire, train, and develop new team members to meet organizational needs
Consciously create a workplace culture consistent with the overall organization's and that emphasizes the identified mission, vision, guiding principles, and values of the organization
Provide timely feedback on employee performance, helping to develop a team members skill where needed, and addressing performance problems
Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities
Coordinate and lead at staff meetings at least once per month
Lead and administer employee performance evaluations and provide feedback on areas of improvement
Create, lead, and motivate teams that achieve maximum site level performance
Travel to Investigator Meetings as needed
Assume responsibility for tasks outside of your current role and to work flexible hours as needed
Step up and fill in as coordinator and assist in lab, if applicable
Assist with ensuring that the Investigator Site File (ISF) is maintained.
Spot check eDocs to ensure all study logs/documents are being maintained including running logs that must be uploaded weekly.
Spot check minimum of twenty (20) eSource visit documentations per week.
Ensure all sponsor and data team queries are resolved within 48 hours.
Ensure all follow up/action items listed on follow-up letters are resolved in 48 hours.
Check IRB portals daily to ensure that site teams are using the correct and most recent version of the informed consent/assent forms. Relay this to CRC’s every morning.
Ensure all sample shipments are completed per protocol & sponsor deadlines are met.
Ensure all equipment that is rented has not expired and file receipt of payment.
Manage and update inventory tracking spreadsheet.
Identify common errors that site staff are making and ensure that a resolution is implemented to prevent and/or address these errors. Keep a record of these errors and re-train, as necessary.
Ensure all sponsor sent packages are received, opened, and confirmed immediately and placed in the appropriate location, i.e., site storage, -20 Freezer, refrigerator, etc.
Ensure all PI/Sub-Investigator signatures, wet and electronic, are collected in a timely manner.
Participate in mock audits/training in conjunction with Regulatory, QA and SIV teams.
Initiate email process to ensure that research team are well trained on the protocol prior to green light.
After we receive greenlight from sponsor/CRO and all mocks and documents completed, initiate greenlight to research team.
After site selection, send sponsor/CRO introduction of executive team (point of contact for budgets & contracts, project management, regulatory & quality assurance team).
Communicate with sponsors on study related requests including closeouts, data queries, study updates, inventory management and documentation requests.
Run assigned studies; recruit subjects, manage inventory, develop recruitment strategies (i.e., visual displays, outreach etc.) monitor storage/freezers, manage shipments coming in and being sent out.
Manage relationships with clinics; ensure protocol understanding, provide training with any gaps in knowledge, provide reports and updates on study progress; ensure compliance documentation.
Ensure CTMS is up to date, that data is entered correctly, upload documentation (audit if these are signed correctly), manage sponsor requests.
Distribute kick off call invites and attend all kickoff calls.
Ensure all temperature alarms are addressed within 24 hours and maintain site temperature logs/calibrations.
Notify monitoring system when new probes/nodes are needed within 45 days of expiration.
Assist with SIV site visits from sponsor in conjunction with CRC, QA, PM, PI.
Conduct SIV Prep Calls with internal staff to mock protocol and comprise a list of questions/ clarifications needed by the sponsor/CRO.
Create and update MSOP, SOP and work instructions.
Complete EDC trainings that sponsors require.
Operate ethically at all times, adhering to SOP’s, and Good Clinical Practice.
Work in conjunction with Regulatory department on IBC submissions and ensure that areas are properly equipped with PPE, biosafety cabinets, hoods, or benches and that they are in proper working condition and calibrated as needed.
Distribute kick off call invites and attend all kickoff calls.
Schedule monitoring visits and close out visits.
Ensure to loop in A/R team once COV has been scheduled for invoicing.
Ensure documents are ready for any IMV & COV (relay information to the site research team & regulatory team).
Work in conjunction with all areas of KUR staff (Regulatory, QA, Operations, Finance, BD, etc.).
Ensure all locations have appropriate staff coverage to avoid enrollment interruptions.
Ensure GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC trainings are completed within 2 weeks of hire and renewed in a timely fashion.
Collaborate with project manager to gather information for completion of feasibility questionnaires in a timely manner.
Stay informed on clinic trends and provide those trends to BD Team.
Keep clinic staff, providers, medical assistants/nurses informed on new studies and patient populations needed for study recruitment.
Provide monthly updates regarding study progress to the PI/Sub-investigators.
Update current study list spreadsheet weekly & ensure all action items are completed.
Maintain 3rd party relationships per sponsor requirements (dry ice vendors, courier services, etc.).
Maintain site supplies, including but not limited to, general site supplies, sponsor specific, and Realtime pay cards.
Ensure Realtime funds remain above the threshold.
Notify monitoring systems internal point of contact when new probes/nodes are needed within 45 days of expiration.
Order supplies & placing rental (centrifuge, temp tales, ultrasound)
Maintain record of Covid-19/Influenza A/B testing & positivity numbers in all clinics you oversee.
Ensure destruction/return of study supplies/equipment/investigational product prior to/on close out visits as directed by the sponsor.
Work with Regulatory dept to ensure record retention is adhered to for all studies.