So sorry, that position has been filled. Please go ahead and submit your application. We may have other positions that would be the perfect fit for you. Alternatively, you may want to apply to one of the following related jobs:

Base Site Managers

New Brunswick, NJ 08901

Posted: 11/25/2024 Employment Type: Contract Industry: IT Job Number: BBBH80998_1732573387 Pay Rate: US$45 - US$55 per hour

Job Description


Job Title: 80998 - 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
Apply Online
Apply with LinkedIn Apply with Facebook Apply with X

Send an email reminder to:

Share This Job:

Related Jobs:

About New Brunswick, NJ

Ready to take the next step in your career? Explore job opportunities in the vibrant area surrounding New Brunswick, New Jersey! Known for its bustling job market and dynamic growth opportunities, this region is a hotbed for talent looking to thrive in a diverse and exciting professional environment. Home to renowned landmarks like the Rutgers University campus and the historic State Theatre, as well as a rich culinary scene offering a taste of authentic New Jersey cuisine, there is no shortage of charm and culture to discover here. From the lively atmosphere of George Street Playhouse to cheering on the Somerset Patriots baseball team at TD Bank Ballpark, New Brunswick and its surrounding areas offer a unique blend of opportunities for career growth and personal enrichment. Dive into our job listings today and unlock your potential in this captivating region!