Reports to: Associate Director of Clinical Research Operations
Position Overview: The Clinical Research Project Manager is an important member of the ClinX Integrated team. Our integrated department can be described as a “Trial Management Company”. We are contracted by either the sponsor or CRO to help manage certain tasks on clinical trials. Our philosophy is that the CRO will handle the data related issues and site monitoring while we handle the back end tasks such as site identification, feasibility review, regulatory, recruitment, site management, home health care, travel and grant management payments/ reconciliation.
Duties and Responsibilities:
- The PM will oversee the overall project tasks to ensure clinical trial deliverables are met. The candidate will the assume responsibility of ensuring the smooth initiation of all clinical study operations under the direction of the department director.
- The PM will also work as a liaison between the different stakeholders within the trial to ensure communication flow stays intact
- Develops and delegates specific guidance documents and tools, including communication flow charts, project workbooks and weekly overview metrics.
- Ensures the study sites are receiving IRB approval, in some cases the PM would develop submission materials, and conduct quality assurance on all regulatory items specific to the trials being worked on
- Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites as needed
- Conducts remote review of data entered electronic Case Report Forms (eCRFs) for completion and correlation relating to site grant payments
- Assess, reviews, and approves/rejects investigative sites for specific trials based off of the trial requirement to conduct the study. Development of the minimum requirements and feasibility development may be needed as well
- Management of specific trial recruitment needs for each of the trials you are PM on. This candidate will not place recruitment ads, but you will review them, ensure protocol accuracy, ensure within required budget, and ensure meeting the expectations of the sponsor for enrollment completion.
- Reviews, approves, and rejects PM’d projects weekly/ monthly company timecards. This would fall in line with ensuring the specific project being managed stays within the expected hours allocated.
- Involved in study specific budgets and change orders as needed. This includes site budgets, study overall budgets, new services budgets, change orders and amendments.
- Accountability and coordination of study specific expenses
- Communicate with the project coordinators to ensure site specific recruitment ads are meeting metrics for site enrollment expectations.
- Manages internal department service line items that pertain the specific trial. i.e recruitment, campaign management site starts up, regulatory, home health care, contracts & budgets, site payments under the oversight of the department director.
- Works as a backup project manager on large global trials, as needed.
- Ownership and/ or delegates taking study specific internal, external, client and vendor meeting agendas & minutes/ follow up action items.
- Oversees and assists on booking, scheduling and overall organization of visits needed for trials opting into the home health care service line
- Manages and oversees the eStaffing projects under the direction of the department director. May also assist in identifying candidates for certain clinical trials that require us to staff specific technicians or coordinators for a study. This could also be for site specific staffing assistance as well and department staffing needs.
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned depending on department overall need
APPLY FOR THIS JOB
- Minimum of 2-5 years of clinical research operations experience either on a private clinical research site level as a CRC or on a sponsor/CRO level as an in house CRA. (Candidates with only academic experience would not qualify for this position)
- Available for full time position (Monday – Friday, 8 Hours Per Day)
- Ability to work remotely during the pandemic but also available to work out of our Quincy, MA. facility permanently once normal office openings begin.
- CCRP, CCRC or CCRA (or equivalent based off experience)
- Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of English, both written and verbal.
- This position involves daily discussions with the sponsor, CRO and/or sites, the candidate must have excellent communication and interpersonal skills with customer service orientation to be qualified for this position
- Working knowledge of Microsoft Office Outlook, Word, and Excel
- Working knowledge of Google Drive, Docs, Spreadsheets and PowerPoint (Preferred)
- Working knowledge of CTMS systems like Realtime or Clinical Conductor (Preferred)
- Experience with Netsuite, salesforce and/or replicon (Preferred)
- Self-starter who thrives in a collaborative, yet less structured team environment