Base Site Managers

Company: Softworld Inc
Location: New Brunswick
Posted on: April 4, 2025

Job Description:

Job Title: Base Site Managers

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

Job Location: New Brunswick, NJ 08901

Onsite Requirements:

Therapeutic Area - Oncology
2 years monitoring experience
Able to travel regionally 8 days per month

Job Description:

Site Management services provide Trial Co-ordination and Site Management services as primary point of contact between the sponsor and the investigational site.
Services/deliverables include ensuring trial sites are inspection ready through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), applicable regulations from start-up through data-base lock.
Further, services/deliverables will include pretrial assessment, site selection, subject recruitment and retention planning, site initiation, monitoring and close-out.
Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Local Trial Manager (LTM) and Central Trial Manager (CTM)/Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.

Deliverables:

Entry (Level 0) / Base (Level 1):

Level 0 (Entry) can perform all the site management services as level 1 under guidance with a reduced
site load and enhanced oversight.
Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory
requirements, ICH-GCP, etc.
Complies with relevant training requirements.
Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site
assessment visits, providing recommendation from local area about site/investigator selection in
collaboration with the trial team, as required.
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff
throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
Drive study compliance by executing activities within site initiation and start-up, site monitoring, site
management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
Ensures site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
Contribute to site level recruitment strategy and contingency planning and implementation in
partnership with other functional areas to achieve clinical research targets.
Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab
kits, etc.) and clinical drug supplies.
This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved
within expected timelines.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting
timelines and documented as appropriate, with supporting data collected and verifiable with
information in the source documents
Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and
essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to
expectations (metrics) and archiving retention requirements, including storage in a secure area at
all times.
Focuses on Investigator engagement through timely follow up with sites.
Completes follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team within 15 working days of monitoring visit. Promptly communicates relevant status information and issues to appropriate stakeholders.
Follows the corresponding Monitoring Guidelines for each assigned trial.
Collaborates with LTM for documenting and communicating site/study progress and issues to trial
central team.
Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues
identified at the site during routine monitoring and other visit types, e.g. On Site Quality
Monitoring Visit (OSQMV).
If applicable, will support negotiation of investigator budgets at site level, support tracking of costs
and ensure payments are made at site level, maintaining site relationships.
May participate in the HA and IEC/IRB submission and notification processes as
required/appropriate.
May contribute as a mentor to a less experienced site manager or to process improvement and
training, as appropriate for business needs (mostly for level 1).
Ensure timely and accurate CTMS data entries / updates.
SMs may also take the role of Independent Drug Monitor (IDM) once additional training is
completed and as required by individual trial.
If applicable, region-specific deliverables will be specified.

Level 1 (Base):

2 years of clinical trial monitoring experience or equivalent industry
experience and/or provider specific academy completion and completion of a monitoring training course

Education and Experience Requirements:

BA/BS degree/Degree in a health or science related field or equivalent industry experience
Specific therapeutic area experience depending on the services need.
Working knowledge of ICH GCP, company standard operating procedures, local laws and
regulations, assigned protocols and associated protocol specific procedures including monitoring
Demonstrate proficiency in IT skills for appropriate software and company systems.
A willingness to travel overnight stay away from home according to business needs.
Proficient in speaking and writing in English and the country language where services will be provided.
Effective communication skills, oral and written.
Experience with monitoring and site management of complex Early Phase of clinical development, as applicable


** 3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.
This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future.
This client is a US Federal Government contractor and is legally required to hire US Citizens. US Citizens will only be considered for this role.
Due to the nature of the work, a United States Government Clearance is required to be eligible for the position. *

Keywords: Softworld Inc, New Brunswick , Base Site Managers, Professions , New Brunswick, New Jersey