Clinical Research Coordinator / Lead Project Manager

At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most.

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.

Join the K2 Family: Where Compassion and Connection Lead the Way! At K2 Medical Research, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. 

We are an equal opportunity employer. We celebrate what makes you uniquely you and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital, or veteran statuses.

We value the differences among our team members and are committed to providing reasonable accommodations for qualified individuals with disabilities. If you require a reasonable accommodation to participate in the job application or interview process, please contact [email protected]. We are here to ensure you have the support and tools you need to shine.