Position: Site Relations Manager
Reports to: VP, Clinical Development
ContraFect Corporation, a late-stage clinical biotechnology company focused on the discovery and development of biotherapeutics for life-threatening, drug-resistant infectious diseases is located in Westchester County, near New York City. ContraFect is dedicated to innovative drug development, leveraging novel technologies to create new therapies that address the high unmet medical needs of patients suffering from serious, antibiotic-resistant infections for which there are limited available treatment options. ContraFect is using their technical expertise to develop biotherapeutics for serious bacterial infections, including those caused by MDR and XDR strains that have high unmet medical needs, particularly products used in hospital-based markets.
An opportunity is available to grow with us in an environment that is both challenging and energetic. ContraFect is seeking self-motivated and collaborative individuals to join our team and to contribute their talent and expertise to the team. We are looking for positive individuals who will add the strength of their personality to our committed and dedicated employee base and contribute to the development of novel therapeutic agents which have the potential to change the therapeutic landscape for treating serious infections.
It is an exciting time in ContraFect’s history as we advance our direct lytic agent (DLA) platform of lysins and amurin peptides. Exebacase (CF-301), our lead lysin, is the first and only direct lytic agent to report promising results in Phase 2 and to advance to Phase 3 clinical development. Earlier this year, the FDA granted Breakthrough Therapy designation to exebacase as a treatment for MRSA bloodstream infections (bacteremia), including right-sided endocarditis, when used in addition to standard-of-care anti-staphylococcal antibiotics. The exebacase Phase 3 study, known as the DISRUPT Study (“Direct Lysis of Staphylococcus aureus Resistant Pathogen Trial”), is ongoing in the United States and will serve as the single pivotal trial to support the BLA. ContraFect also has an active discovery pipeline of DLAs discovered at ContraFect which are progressing towards the clinic with support from major funding agencies. Our lead IND candidate, CF-370, is a lysin targeting MDR Pseudomonas aeruginosa, identified as a serious threat in the CDC’s Antibiotic Threats in the US, 2019 report., while our amurin program targets Gram-negative ESKAPE pathogens.
ContraFect has been highly successful in raising significant capital to fund our continued commitment to innovative R&D. This includes non-dilutive funding up to $86.8 million from BARDA for exebacase clinical development against S. aureus infections, $18.9 million from CARB-X for antibacterial research, $7.2 million from USAMRMC to advance CF-296 for osetomeyelitis, an additional $6.94 million from CARB-X to support the development of the amurin platform against Gram-negative ESKAPE pathogens, and funding from the Cystic Fibrosis Foundation. ContraFect has also conducted numerous capital raises, including public and private offerings. The gross proceeds from the most recent public offering were approximately $52.5 million, and an additional $3 million from a concurrent private placement transaction with Pfizer, the pharmaceutical company’s second investment in ContraFect.
The Site Relations Manager (SRM) will be responsible for maintaining a positive relationship between ContraFect and the study sites, training of site staff to improve recruitment and study quality oversight (source data verification) of assigned studies. The SRM will execute these responsibilities in accordance with ContraFect’s standard operating procedures (SOP)/processes. This position will also take on additional project management responsibilities as delegated by the Clinical Operations Lead. This role requires an individual with demonstrable clinical operations and/or study coordinator experience and proven expertise in customer service. Travel within the contintential US visiting study sites will be required when travel is deemed safe after the COVID-19 pandemic. The ideal candidate will have a track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry.
Support site recruitment efforts and enhance enrollment of the clinical study by
- Supporting the VP, Clinical Development in buidling relationships with investigators, study coordinators, and other key stakeholders at clinical sites to reduce barriers to enrollment and enhance screening activities at the clinical sites.
- Identify potential new sites and work with CRO/ContraFect clinical operations to progress new sites to activation by providing documents, discussing the study with investigators and study coordinators, and supporting quick obtainment of contracts/budgets, IRB/EC approval, and essential documents.
- Review pre-screening, screening, and enrollment activities of sites to determine issues at sites, reporting to the CRO/ContraFect CRAs and clinical operations teams, and setting up engagement activities (e.g., face-to-face meetings, telephone calls) with the sites to discuss these issues.
- Develop study related materials to help with recruitment (e.g., posters, flyers, pocket cards, badges, buttons, dear colleague letter)
- Visiting sites in person (at least 6 to 8 sites per month) and telephone communications (at least 10 sites per month) for Site Initiation Visits (SIV) to motivate sites about the study and work through any issues the sites are experiencing (up to approximately 50% travel when travel deemed safe after COVID-19 pandemic)
- Training site personnel, including investigators, study coordinators, and other key personnel in screening, recruitment, and study procedures based upon best practices and lessons learned from other sites
- Engagement researchers and clinicians at public events (e.g., conferences, patient organizations)
Support the clinical operations group from start-up through close out
- Provide input to agenda, discuss relevant advice, and updates sites on study progress at study coordinator and investigator meetings to help sites understand screening and other activities of the study
- Perform site monitoring oversight activities for assigned sites across designated projects to ensure quality and integrity of data, particularly in regards to the primary endpoint
- Work with CRO/Contrafect clinical operations teams team to help ensure data accuracy and resolve queries prior to interim analysis (e.g., adjudication committees, Data Safety Management Board), and database lock
- Update the CRO/Contrafect clinical operations group to solve outstanding issues leading to gaps in recruitment and issues with study procedures
- Collaborate with external partners to increase return to clinical visits (e.g., home health company, transportation) and minimize missing data
To create a positive and impactful site experience, all roles will be accountable for
- Identifying and prioritising unique site needs with ongoing, regular communication, teamwork and coordination
- Sharing relevant insights back to the organisation and following compliance guidelines
- Bachelor of Science degree or equivalent combination of education and work experience.
- Minimum of 5 years late stage clinical trial experience with a proven track record of clinical monitoring and/or study coordinator experience, preferably for some part, in a Lead CRA or Study Coordinator role
- Thorough knowledge of clinical trial processes including a strong grasp of US guidelines and regulations
- Thoughtful collaborator and excellent relationship-building skills with the ability to work effectively with internal and external stakeholders
- Strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity in a remote working environment.
- Strategic, with an ability to incorporate new data into clinical development planning
- Excellent technical skills, proficient in MS Word, Excel, Powerpoint, etc.
- Ability to work efficiently from home based office with occasional travel to main office
- Travel up to approximately 50% within contintental Unites States when travel deemed safe after COVID-19 pandemic
Respect. People matter.
Patient- Focus. Act with urgency and passion to save lives.
Leadership. Set high standards, and empower others to do the same.
Innovation. Challenge the status quo to deliver solutions.
Collaboration. Work together to achieve our vision.
Quality. Strive for excellence in all that we do.
Integrity. Courage to be honest, ethical, and transparent
Please fill out the form below to submit your resume.