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Clinical Site Relationship Specialist

Waltham, MA 02451

Posted: 07/16/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 610037 Is job remote?: No Country: United States

Job Description

Position Overview:

We seek a highly motivated and experienced professional for a Clinical Site Relationship Specialist. The successful candidate will be responsible for helping to develop and maintain strong relationships with site investigators, study teams, and other key stakeholders involved in clinical trials, site start-up, and clinical monitoring. The CSS will assist in execution of site selection plans, establish strong “sponsor of Choice” relationships, and ensure trials are executed on time with high quality.

Key Responsibilities:
 
  • Assist in building and managing clinical site relationships (investigators, site staff, KOLs etc.) for local, regional, and global clinical trials across one or more programs that have been outsourced to a CRO Partner.
  • Cultivate productive relationships with key stakeholders, such as site investigators, study coordinators, and research professionals, fostering a collaborative and mutually beneficial environment.
  • Collaborate with cross-functional teams (clinical operations, regulatory affairs, medical affairs, etc.) to ensure seamless communication and coordination between the company and the participating sites.
  • Participate in site visits (domestic/international) to build company awareness, enhance investigator relationships, address concerns and ensure adherence to study protocols, regulations, and ethical practices.
  • Participate in execution of protocol feasibility.
  • Assist in execution of site selection plan including site feasibility questionnaires, pre-study visits and final site selection.
  • Contribute to execution of site-specific plans, including investigator meetings, site initiation, recruitment strategies and plans, patient retention, and quality metrics, to ensure the timely delivery of high-quality clinical trial data.
  • Assist in assessing site performance and proactively identify opportunities to optimize trial processes, mitigate risks, and resolve operational or compliance issues.
 
  • Act as a trusted resource to investigators and study teams, guiding study design, protocol expectations, recruitment strategies, and best practices for operational excellence.
  • Collaborate closely with internal study team and the CRO and vendors to facilitate the exchange of information, resources, and innovative ideas that contribute to the success of clinical trials and ultimately improve patient outcomes.
  • Participate in IRB/EC initial and amendment submissions including review of ICF and patient facing documents, IRB submissions, and site training.  Assist with facilitation of clinical trial contract and budget negotiations.
  • Participate in study level vendor selection and facilitate patient recruitment/retention, home health and patient travel and reimbursement vendors.
  • Collaborate with Clinical Project Management to facilitate interactions between sites and vendors for site training, provisioning supplies, tracking samples, data queries and issue resolution.
  • Execute monitoring plan and monitoring oversight plan. Review trip reports and follow action items to resolution. Participate in conduct of monitoring oversight visits as required.


Qualifications and Skills:
 
  • BS/BA in a scientific or healthcare-related discipline.
  • Experience 3 years clinical research/operations, site relationship management, or related pharmaceutical or biotechnology industry roles. 
  • Understanding of clinical trial operations, procedures, and industry regulations (e.g., ICH-GCP, FDA, EU, APAC, LATAM guidelines).
  • Track record in building and maintaining strong relationships with site investigators, key stakeholders, and CROs.
  • Ability to influence without authority and effectively negotiate at various organizational levels.
  • Strong analytical and problem-solving skills, with a commitment to data-driven decision-making.
  • Exceptional communication and presentation skills, both written and verbal, coupled with the ability to convey complex information clearly and concisely.
  • High adaptability, resilience, and flexibility in a dynamic, fast-paced work environment.

 
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About Waltham, MA

Discover exciting job opportunities in the vibrant area surrounding Waltham, Massachusetts! Known for its rich history, picturesque scenery, and bustling economy, Waltham offers job seekers a unique blend of innovation and tradition. Home to renowned universities, cutting-edge technology companies, and a thriving cultural scene, this city has something for everyone. Explore job listings in this region and unlock the door to a career filled with growth, charm, and endless possibilities. From strolling along the Charles River to catching a game at Fenway Park, there's no shortage of enchanting experiences waiting for you in the Waltham area. Start your job search today and embark on a rewarding career journey in one of the most inviting locations in the Northeast.

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