Job Title: Assistant Director, Team 1
FLSA Classification: Exempt
- PURPOSE: To assist in the provision of oversight, development, leadership, direction and management of the conduct/execution of multiple projects and programs for research related activities and personnel within the early phase department at the company. To carry out these responsibilities while ensuring subject/patient safety and while following applicable standard operating procedures (SOPs), policies and procedures, federal regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonization (ICH) guidelines, Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. To promote, support and supervise the team’s completion of the above while complying with the company’s mission statement and employee manual.
- JOB RELATIONSHIPS:
Reports to: Director, Clinical Operations
Senior. V.P. of Operations
Direct Report/Workers Supervised: Team Lead I, Team 1; Clinical Research Coordinators (CRCs); Clinical Research Coordinator Assistants (CRCAs); PRN Research Technicians
Interrelationships: Works closely with other team leads, department managers, regulatory, laboratory and business operations personnel, sponsor/contract research organizations (CROs) and outside vendors. Works closely with physician investigators and their staff to ensure subject safety, effective communication and successful conduct of studies.
- ESSENTIAL JOB FUNCTIONS:
- Represent the company in a professional and courteous manner (verbal, written and in appearance) when interacting with the company’s staff, sponsors/CROs, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physicians’ offices;
- Ensure the maintenance of confidentiality by team members of subject/patient information as appropriate and as bound by Confidentiality Agreements with the company, between the company and sponsors/CROs and between the company and other entities while abiding by HIPAA regulations;
- Able to perform all duties as specified in the company’s Team Lead I, Team 1 job description;
- Take ownership for meeting project objectives and deliverables according to study timeline;
- Overall oversight of Team 1 and everyone’s duties and success;
- Forecast for the department;
- Drive project execution to meet project schedule, and quality requirements;
- Back up Team Lead I, Team 1 as needed;
- Create study specific timelines and determine clinical team schedules according to assigned protocols;
- Manage, coordinate and ensure PRN staff are fully trained and available to meet department needs for studies; ;
- Create overnight subject scheduling and assignments;
- Review budgets for meals and supplies needed for each study;
- Manage procurement of medical supplies and equipment for team’s studies;
- Manage pharmacy resources for team’s studies;
- Follow and ensure compliance with the company’s SOPs by Team 1 team members;
- Assist in management of all team members involved in the conduct of the company’s studies to foster growth and success of the company’s and employees;
- Provide a leadership role in developing, implementing and evaluating Team 1 staff and the conduct of studies;
- Lead activities performed by team to improve organizational performance;
- Screen/interview/hire team members for early phase team;
- Train, mentor and supervise early phase team members to include staff evaluations and counseling’s;
- Identify department needs for Business Development;
- Review rosters daily;
- Drive recruitment and ensure that enrollment goals for all studies assigned to the team are met and assist with enrollment on other teams to ensure overall success of the company;
- Interface with budget and contract personnel to assist with initial budget creation and review and when amendments to the protocol or study budget are made;
- Work closely with the regulatory department to ensure accuracy of informed consent documents, subject/patient stipend, training records and other documents necessary as part of the conduct of clinical research studies;
- Establish and maintain avenues for dissemination of vital communication to the Director, Clinical Operations; Senior VP of Clinical Operations; President/CEO; other team leads and department managers;
- Ensure continuous high level involvement by principal investigators as required by FDA regulations/ICH guidelines and the company’s SOPs by maintaining frequent communications with and training of physician investigators and their staff;
- Overall responsibility for ensuring department budget and revenue goals are met;
- Attend manager meetings and trainings as well as other planning/organizational meetings as required by the Director, Clinical Operations; Senior VP of Clinical Operations; President/CEO; other team leads and department managers;
- Attend meetings to include but not limited to PSVs, pre-Site Initiation Visits, SIVs, periodic team meetings, budget meetings, trainings, etc.
- Attend recruitment meetings and develop strategies to meet enrollment goals;
- Provide pertinent communications (written and oral) of sufficient frequency to effectively disseminate information and/or to gain feedback regarding the team’s performance and any issues requiring intervention/management;
- Conduct mock study runs;
- Management of the startup, conduct and close out of studies assigned to Team 1;
- Ensure data integrity for all work performed by team members through close oversight and review of source document creation and utilization in the study, of data collection and entry procedures, and by performing periodic quality control reviews of completed work;
- Ensure meeting team budget and revenue;
- Provide supervision and oversight of team members to the degree necessary by reviewing/monitoring study-specific logs, efindings form reflecting the company’s internal queries, RealTime CTMS entries, monitoring visit reports/follow-up letters, and by interfacing with sponsor/CRO representatives;
- Other duties as assigned.
- PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:
- Work is normally performed in a typical interior/office work environment;
- Travel required locally as well as within the continental United States. Travel from time to time may include locations outside of the North American continent;
- Exposure to human bodily fluids;
- Laboratory procedures to obtain specimens and processing of specimens;
- Subject/patient care;
- Daily computer use;
- Availability during weekends, holiday, and outside of core business hours may be required based on the demands of the projects being executed;
- Ability to properly lift up to 35 pounds and occasionally more than 35 pounds;
- Ability to drive and daily availability of an automobile.
- MINIMUM REQUIREMENTS:
Education: Bachelor’s degree or higher.
- Minimum of one year experience conducting or managing clinical pharmaceutical/device research studies within the field of clinical research preferred but not required;
- Minimum of three years previous management experience is required;
- Previous early phase management experience preferred but not required.
Knowledge and Skills:
- Demonstrates core values & most skills needed in department;
- Able to demonstrate current knowledge of federal regulations/ICH guidelines and GCPs, IRB requirements, HIPAA laws, the company’s SOPs, the company’s employee manual and some knowledge of human resource laws;
- Possess strong clinical skills, i.e. accurate performance of ECGs, vital signs, subject/patient medical history, completion of visit specific source documents, obtain and process laboratory specimens, etc.;
- Proven ability to handle a large volume of paperwork efficiently and accurately;
- Ability to organize people and manage resources to complete projects in a timely manner and with accuracy;
- Demonstrate moderate to high level of computer skills including Microsoft Office, data entry systems utilized by sponsors, and RealTime software;
- Assists with training company new hires.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything