What are the responsibilities and job description for the Lead Project Manager position at K2 Medical Research?
K2 is seeking an experiencedLead Clinical Research Coordinator/Project Manager to support our clinic out of Orlando (Maitland), FL. 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
At K2 Med, 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 thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.
We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at Talent@k2med.com, and we'll ensure you have everything you need to shine.
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
- 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
- Bilingual in Spanish/English highly desired.
- 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 Parkinson's (neurodegenerative disease) 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.
- Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
- 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
- PTO of 16 days per year, 17 days after the first year of FT employment
- 9 paid Holidays
- K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.
At K2 Med, 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 thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.
We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at Talent@k2med.com, and we'll ensure you have everything you need to shine.