Base Site Managers

Job Title: Base Site Managers

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. *