K2 is seeking an experienced
Lead Clinical Research Coordinator/Project Manager to support our clinic out of
Boston (Foxborough), MA. This position will supervise a team of Project Managers; assist the Site Director with day-to day operations; and provide leadership and support to clinical staff to ensure high quality/high volume of work, efficient productivity, and maintain effective + positive working relationships with patients, sponsors, physicians, and employees.
Primary Responsibilities:- Train new and current Project Managers and Clinical Research Assistants to ensure effective coordination of training activities in the clinical trials processes
- Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
- Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate
- Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator
- Articulate all pertinent issues to the Pl or document by email/letter or during meetings
- Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
- Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
- Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Medical Research
- Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
- Maintain timely K2 Medical Research source documentation as well as sponsor required information.
- Dispense and maintain accurate records of study medication
- Educate patients and family regarding their particular study and clinical drug trials in general.
- Complete all monitor and sponsor queries in a timely manner
- Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study
Knowledge, Skills, and Abilities:- Outstanding verbal and written communication skills
- Excellent interpersonal and customer services skills
- Strong time management and organizational skills In depth knowledge of industry regulations
- Proven ability to and foster mentoring relationships
- Ability to create momentum and foster organizational change
Qualifications:- HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
- At least two (2) full years of Clinical Research Coordinator or Project Manager experience required.
- Prior experience in a clinical environment preferred. Experience in clinical research and psychiatric is ideal.
- Phlebotomy, LPN, RN, or other medical licensure or certification preferred.
- CCRC certification preferred.
- Strong working knowledge of GCP and FDA guidelines.
- Knowledge of medical terminology.
- BLS Healthcare Provider desired.
- Applicants that do not meet 100% of the above qualifications but who have a combination of related education and applicable experience may be considered upon approval.
Your growth and well-being are our priority. Our comprehensive benefits package for full-time employees includes medical, dental, and vision options, supplemental insurance plans, 401(k) with immediate employer match, generous paid time off, and paid holidays. Most notably, we support a healthy work-life balance through a four-day work week, consisting of 10-hour shifts from Monday through Thursday. Fridays are reserved only for critical business needs or administrative tasks; otherwise, they are your chance to kick-start your weekend.
